Small and similar amounts of micromotion in an anatomical stem and a customized cementless femoral stem in regular-shaped femurs: A 5-year follow-up randomized RSA study

Background and purpose

High primary stability is important for long-term survival of uncemented femoral stems. Different stem designs are currently in use. The ABG-I is a well-documented anatomical stem with a press-fit design. The Unique stem is designed for a tight customized fit to the cortical bone of the upper femur. This implant was initially developed for patients with abnormal anatomy, but the concept can also be used in patients with normal femoral anatomy. We present 5-year radiostereometric analysis (RSA) results from a randomized study comparing the ABG-I anatomical stem with the Unique femoral stem.

Patients and methods

100 hips with regular upper femur anatomy were randomized to either the ABG-I stem or the Unique femoral stem. RSA measurements were performed postoperatively and after 3, 6, 12, 24, and 60 months.

Results

RSA measurements from 80 hips were available for analysis at the 5-year follow-up. Small amounts of movement were observed for both stems, with no statistically significant differences between the 2 types.

Interpretation

No improvement in long-term stability was found from using a customized stem design. However, no patients with abnormal geometry of the upper femur were included in this study.High mechanical stability is a crucial factor for correct performance of uncemented femoral stems. Micromovements along the implant-bone interface may prevent ingrowth of bone to the surface of the prosthesis, and it may lead to the formation of a fibrous membrane and eventually to loosening of the implant. The critical thresholds of micromovements that can be tolerated are not exactly known, but they are probably dependent on both patient- and implant-specific factors (Viceconti et al. 2006). It has been shown, however, that interfacial motion of around 40 μm leads to partial bone ingrowth whereas motions exceeding 150 μm completely prevent ingrowth of bone (Pilliar et al. 1986, Jasty et al. 1997).Uncemented, customized femoral stems are mainly designed and manufactured for patients with abnormal size and shape of the proximal femur, but this does not preclude their use in patients with regular-shaped proximal femurs. The requirement for maximum primary stability with uncemented off-the-shelf stems also applies to customized stems. The optimized fit and fill of a customized stem should theoretically promote even better mechanical fixation than with standard implants.Radiostereometric analysis (RSA) enables measurement of migration and rotation in the range of 0.1 mm and 0.05º, respectively (Selvik 1989, Kadar et al. 2011). There is a correlation between postoperative migration of femoral stems and early loosening (Freeman and Plante-Bordeneuve 1994, Linder 1994, Karrholm et al. 2006, Karrholm 2012). On the other hand, a new implant showing large degrees of micromovement should not necessarily be regarded as having a performance equivalent to long-term failure (Karrholm et al. 2006). Recently published studies reporting medium- to long-term RSA results will probably contribute to a better understanding of the topic (Nieuwenhuijse et al. 2012, Rohrl et al. 2012).This randomized study was performed as part of the clinical documentation of the Unique customized stem (Scandinavian Customized Prosthesis (SCP), Trondheim, Norway), to compare the migration pattern of the Unique stem with that of a standard anatomical uncemented stem with a clinically well-proven stem design (the ABG-I).Our aim was to measure migration of the Unique customized stem and the ABG-I stem using RSA. Our hypothesis was that there would be no difference in migration between the 2 types of uncemented femoral stems in patients with regular anatomy in the upper femur.     

No benefit of a proximal stem centralizer in cementing of a femoral prosthesis in human cadavers

Background and purpose

A proximal stem centralizer may be beneficial regarding cementing pressures, cement penetration, and stem alignment. We measured these parameters when cementing a mat-surfaced femoral component with and without the use of a proximal stem centralizer.

Material and methods

8 femoral prostheses with proximal centralizers and 8 femoral prostheses without proximal centralizers were cemented according to third-generation cementing technique in 8 pairs of embalmed cadaveric femora. We recorded intramedullary pressures (peak levels, the area under the pressure curves and mean pressure) with 6 pressure transducers during stem cementation. Computer tomographic scanning of specimens was performed to evaluate stem alignment after surgery. Thickness of the cement mantle, cement penetration, and stem centralization at the metaphyseal part of the femur were measured on cross sections using stereology.

Results

There were no statistically significant differences in measured pressure and cement penetration values between the groups. There was similar cement distribution around the stems; however, in using a proximal centralizer, the cement mantle tended to be thinner laterally. Moreover, we found a larger variation in stem alignment on lateral projection in the proximal centralizer group.

Interpretation

No benefits regarding intramedullary pressures and cement penetration were obtained from cementation of a straight stem with a proximal stem centralizer. However, there was an increased risk of inferior stem positioning in the reamed medullary cavity using the centralizing device.An adequate cement mantle is important for long-term fixation of the cemented femoral component in hip arthroplasty (Malchau et al. 2002, Berry 2004). While the cause of aseptic loosening of femoral implants is multifactorial, central positioning of the stem in the medullary cavity is preferable regardless of implant geometry, implant surface finish, or implant design. The use of distal stem centralizers helps to control alignment of the stem, avoiding direct contact between the bone and the tip of the prosthesis (Egund et al. 1990, Berger et al. 1997). However, this device alone cannot prevent cement mantle deficiencies, especially in the proximal region of the femur (Berger et al. 1997, Crawford et al. 1999, Breusch et al. 2001).Promising results using the proximal stem centralizer—regarding both prosthesis alignment and cement mantle thickness—have been reported in retrospective studies (Goldberg et al. 1998, Jarrett and Lachiewicz 2005). Experimental trials have also shown that a proximal centralizer can increase the intramedullary pressures in the proximal region of the femur, thereby enhancing the cement-bone interlock (Gozzard et al. 2003, 2005). Even so, no reports have been published on the relation between cementing pressures, cement penetration, cement mantle thickness, and the use of a proximal centralizer in a true-to-life study set-up. We compared these parameters during cementation of a Bi-Metric femoral prosthesis with and without a custom-made proximal stem centralizer.     

Hydroxyapatite coating does not improve uncemented stem survival after total hip arthroplasty!: An analysis of 116,069 THAs in the Nordic Arthroplasty Register Association (NARA) database

ResultsUnadjusted 10-year survival with the endpoint revision of any component for any reason was 92.1% (CI: 91.8–92.4). Unadjusted 10-year survival with the endpoint stem revision due to aseptic loosening varied between the stem brands investigated and ranged from 96.7% (CI: 94.4–99.0) to 99.9% (CI: 99.6–100). Of the stem brands with the best survival, stems with and without HA coating were found. The presence of HA coating was not associated with statistically significant effects on the adjusted risk of stem revision due to aseptic loosening, with an HR of 0.8 (CI: 0.5–1.3; p = 0.4). The adjusted risk of revision due to infection was similar in the groups of THAs using HA-coated and non-HA-coated stems, with an HR of 0.9 (CI: 0.8–1.1; p = 0.6) for the presence of HA coating. The commonly used Bimetric stem (n = 25,329) was available both with and without HA coating, and the adjusted risk of stem revision due to aseptic loosening was similar for the 2 variants, with an HR of 0.9 (CI: 0.5–1.4; p = 0.5) for the HA-coated Bimetric stem.InterpretationUncemented HA-coated stems had similar results to those of uncemented stems with porous coating or rough sand-blasted stems. The use of HA coating on stems available both with and without this surface treatment had no clinically relevant effect on their outcome, and we thus question whether HA coating adds any value to well-functioning stem designs.Hydroxyapatite (HA) is thought to improve early implant ingrowth and long-term stability in bone (Overgaard et al. 1997), and many stems intended for uncemented total hip arthroplasty (THA) are thus manufactured with HA coating. Several uncemented stems are only available with HA coating. Some HA-coated stems have excellent long-term outcomes in terms of the risk of revision, both for any reason and due to aseptic loosening (Capello et al. 2003, Shah et al. 2009). Registry data from Norway and Finland also indicate that certain HA-coated stems have excellent survivorship up to 10 years (Eskelinen et al. 2006, Hallan et al. 2007, Makela et al. 2008).On the other hand, a number of studies on stem survival in the setting of randomized trials or smaller observational studies have failed to show beneficial effects of HA coating on clinical outcome and implant survival when compared to alternatives such as porous coating and sand-blasted rough surfaces (McPherson et al. 1995, Tanzer et al. 2001, Kim et al. 2003, Parvizi et al. 2004, Sanchez-Sotelo et al. 2004). Meta-analyses that have pooled data from randomized or cohort studies have come to the conclusion that there is “[…] no clinically beneficial effect to the addition of HA to porous coating alone in primary uncemented hip arthroplasty” (Gandhi et al. 2009, Li et al. 2013). In addition, a Danish registry analysis found that the use of HA coating does not reduce the risk of stem revision (Paulsen et al. 2007). Furthermore, a comparison of 4,772 uncemented Bimetric stems with or without HA coating implanted between 1992 and 2009 did not reveal any difference in survival between the 2 variants (Lazarinis et al. 2011).HA was initially introduced as an implant coating to speed up and facilitate ongrowth and ingrowth of bone and thereby improve fixation, based on comprehensive preclinical and promising clinical documentation (Geesink et al. 1987, Bauer et al. 1991, Overgaard et al. 1997, Karrholm et al. 1998). Later on, concerns were raised due to findings of delamination and generation of HA particles originating from the coating with the potential to trigger osteolysis, acceleration of polyethylene wear, and subsequent implant loosening (Bloebaum and Dupont 1993, Morscher et al. 1998, Lazarinis et al. 2010). Today, there is renewed interest in HA coatings due to possible properties as a carrier for agents aimed at preventing infection (Ghani et al. 2012). Theoretical arguments for and against the use of HA coating can therefore be found. Given the renewed interest in uncemented stems—instigated by favorable outcomes after uncemented stem fixation in younger patients—the question of whether HA coating is beneficial or not is highly relevant (Eskelinen et al. 2006, Hooper et al. 2009, Swedish Hip Arthroplasty Register 2011). We therefore investigated uncemented stems with and without HA coating that are in frequent use in the Nordic countries, regarding early and long-term survival.     

Uncemented femoral revision arthroplasty using a modular tapered,fluted titanium stem: 5- to 16-year results of 163 cases

Background and purpose —

Due to the relative lack of reports on the medium- to long-term clinical and radiographic results of modular femoral cementless revision, we conducted this study to evaluate the medium- to long-term results of uncemented femoral stem revisions using the modular MRP-TITAN stem with distal diaphyseal fixation in a consecutive patient series.

Patients and methods —

We retrospectively analyzed 163 femoral stem revisions performed between 1993 and 2001 with a mean follow-up of 10 (5–16) years. Clinical assessment included the Harris hip score (HHS) with reference to comorbidities and femoral defect sizes classified by Charnley and Paprosky. Intraoperative and postoperative complications were analyzed and the failure rate of the MRP stem for any reason was examined.

Results —

Mean HHS improved up to the last follow-up (37 (SD 24) vs. 79 (SD 19); p < 0.001). 99 cases (61%) had extensive bone defects (Paprosky IIB–III). Radiographic evaluation showed stable stem anchorage in 151 cases (93%) at the last follow-up. 10 implants (6%) failed for various reasons. Neither a breakage of a stem nor loosening of the morse taper junction was recorded. Kaplan-Meier survival analysis revealed a 10-year survival probability of 97% (95% CI: 95–100).

Interpretation —

This is one of the largest medium- to long-term analyses of cementless modular revision stems with distal diaphyseal anchorage. The modular MRP-TITAN was reliable, with a Kaplan-Meier survival probability of 97% at 10 years.Long-term outcome of femoral revision arthroplasty depends on proper restoration of joint mechanics by reconstructing the anatomic center of rotation in combination with fixation that provides long-term stability (Gravius et al. 2011).The published medium- to long-term survival rates of cemented revision THA are between 35% and 91% (Kavanagh and Fitzgerald 1985, Retpen et al. 1989, Stromberg and Herberts 1996, Weber et al. 1996). One stage cemented stem revision leads to increased bone loss (Rader and Eulert 2005) and is associated with a much higher rate of re-revision than cementless femoral stem revision (Dohmae et al. 1988). Cemented revision stems only appear to be advisable for less active patients with an average life expectancy of less than 10 years (Weiss et al. 2011). In comparison, uncemented revision hip arthroplasty gives medium- to long-term survival rates of 60–97% (Head et al. 2001, Engh et al. 2002, Kwong et al. 2003).Over the years, uncemented modular revision stems have become increasingly popular (Fink et al. 2009). In complex revision surgery, modular uncemented femoral implants may overcome the limitations of non-modular and mostly straight stems—for example, the difficulty in establishing femoral leg length, femoral anteversion, and soft tissue tension (Berry 2002, Mumme et al. 2004, Gutierrez et al. 2007). Modular cementless implant systems with a distal diaphyseal press-fit concept provide greater variability in difficult anatomical situations than non-modular revision stems (Berry 2002). The modular-designed components offer the opportunity to customize the prosthesis intraoperatively to the individual anatomical situation, allowing nearly physiological joint reconstruction (Gravius et al. 2011).Based on published studies, the modular cementless MRP-TITAN revision stem with its distal diaphyseal fixation concept has well-proven short-term effectiveness in femoral revision, especially for large femoral defects (types IIC and III, as described by Paprosky et al. (1990)). Previous studies have shown low mechanical failure rates of 2–5% after 4–5 years of follow-up (Wirtz et al. 2000, Mumme et al. 2004, 2007).Due to the relative lack of medium- to long-term results of femoral modular cementless revision surgery in the literature, we investigated the clinical and radiographic medium- to long-term outcome of femoral revision arthroplasty with the MRP-TITAN stem in a consecutive patient series.     

Design modifications of the uncemented Furlong hip stem result in minor early subsidence but do not affect further stability: A randomized controlled RSA study with 5-year follow-up

Background and purpose —

Even small design modifications of uncemented hip stems may alter the postoperative 3-D migration pattern. The Furlong Active is an uncemented femoral stem which, in terms of design, is based on its precursor—the well-proven Furlong HAC—but has undergone several design changes. The collar has been removed on the Active stem along with the lateral fin; it is shorter and has more rounded edges in the proximal part. We compared the migration patterns of the uncemented Furlong HAC stem and the modified Furlong Active stem in a randomized, controlled trial over 5 years using radiostereometry (RSA).

Patients and methods —

50 patients with primary osteoarthritis were randomized to receive either the HAC stem or the Active stem. The patients underwent repeated RSA examinations (postoperatively, at 3 months, and after 1, 2, and 5 years) and conventional radiography, and they also filled out hip-specific questionnaires.

Results —

During the first 3 months, the collarless Active stem subsided to a greater extent than the collar-fitted HAC stem (0.99 mm vs. 0.31 mm, p = 0.05). There were, however, no other differences in movement measured by RSA or in clinical outcome between the 2 stems. After 3 months, both stem types had stabilized and almost no further migration was seen.

Interpretation —

The Active stem showed no signs of unfavorable migration. Our results suggest that the osseointegration is not compromised by the new design features.Since the introduction of the Charnley cemented hip stem, it has been emphasized that immediate stability is of great importance for achievement of long-term stem survival (Loudon and Charnley 1980). Nowadays, it is well documented that different design features influence the migration pattern of the stem. Highly polished, collarless cemented stems like the Exeter continuously subside within the cement mantle without compromising the long-term survival of the stem (Stefansdottir et al. 2004, Nieuwenhuijse et al. 2012). Uncemented stems depend on osseointegration to stabilize, and the common perception is that postoperative migration should not be tolerated (Kirk et al. 2007, Demey et al. 2011, Gortchacow et al. 2012). According to several RSA investigations, however, many modern uncemented stems show a small degree of initial migration before osseointegration occurs (Strom et al. 2006a,b, 2007, Campbell et al. 2011).Over the last decade, long-term follow-up has shown good results for the contemporary uncemented stems (McNally et al. 2000, Skinner et al. 2003, Eskelinen et al. 2006, Sharma and Brooks 2006, Gabbar et al. 2008, Rajaratnam et al. 2008, Hailer et al. 2010, Vidalain 2011), including a 99% survival rate for the Furlong HAC stem (JRI Ltd., London, UK) at 13–15 years (Shetty et al. 2005). The design of the Furlong HAC stem has not changed since its introduction in the mid-eighties, but demands for a more modern, shorter and less bulky femoral stem have led to the introduction of a modified version of the Furlong HAC stem with the aim of making it easier to implant: the Furlong Active stem (JRI Ltd, London, UK). From here on, the stems will be referred to as the HAC and the Active. The lateral fin, which was originally designed to improve rotational stability, has been removed. The rationale for this change is the risk of fracturing the trochanter major when using the lateral fin cutter (“breadknife”) in order to make room for the fin. The Active stem has more rounded edges both medially and laterally in the proximal part (Figure 1). Proximally, the Active stem is slightly double-tapered whereas the HAC stem is parallel-sided in the coronal plane. In the AP view, the central section of the stem has more or less remained the same in the form of a cone to provide transfer of body weight under hoop stress. The transition zone from the cone-shaped proximal section to the distal cylindrical section is less distinct in the Active stem, and the distal cylindrical section is shorter. Similarly to the HAC stem, it is made from forged titanium alloy and is vacuum plasma-sprayed with a 200-µm-thick layer of Supravit (150-µm hydroxyapatite ceramic on 50-µm titanium substrate), which provides a high-density coating without metal-to-bone contact.Open in a separate windowFigure 1.A. Furlong HAC. B. Furlong Active, both with tantalum markers. C. Superimposition of outlines (right image).It is important that the postoperative 3-D migratory pattern is well established before a prosthesis of new or modified design is implanted on a larger scale, thereby reducing the risk of potential future complications for patients (Karrholm et al. 1997). The most accurate radiographic method used to identify early warning signs of prosthesis migration and to predict long-term results with a specific prosthesis is radiostereometry (RSA) (Valstar et al. 2005).The main goal of our study was to compare the 3-D migration patterns of the Active stem and the well-proven HAC stem using RSA. We wanted to determine if the design changes would have any impact on the migration behavior, influence the osseointegration, and thereby affect the long-term result.     

Stem subsidence of polished and rough double-taper stems: In vitro mechanical effects on the cement-bone interface

Background and purpose Many clinical reports have indicated that polished hip stems show better clinical results than rough stems of the same geometry. It is still unknown, however, what the mechanical effects are of different surface finishes on the cement at the cement-bone interface. We compared mechanical effects in an in vitro cemented hip arthroplasty model.Methods Two sizes of double-taper polished stems and matt-processed polished stems (rough stems) were fixed into composite femurs. A 1-Hz dynamic load was applied to the stems for 1 million cycles. An 8-h no-load period was set after every 16 h of load. Stem subsidence within the cement, and compressive force and horizontal cement creep at the cement-bone interface, were measured.Results Compared to rough stems, stem subsidence, compressive force and cement creep for polished stems were a maximum of 4, 12, and 7-fold greater, respectively. There was a strong positive correlation between stem subsidence and compressive force for polished stems. In contrast, a strong negative correlation was found between stem subsidence and compressive force for rough stems. There was also a statistically significant relationship between compressive force on the cement and cement creep for the polished stems, but no significant relationship was found for rough stems.Interpretation This is the first evidence that different surface finishes of stems can have different mechanical effects on the cement at the cement-bone interface. Stem subsidence in polished stems resulted in compressive force on the cement and cement creep. The mechanical effects that polished taper stems impart on cement at the cement-bone interface probably contribute to their good long-term fixation and excellent clinical outcome.Many studies have shown that the long-term survival of a polished stem is better than that of a rough-surfaced stem of the same geometry in cemented total hip arthroplasty (THA) (Dall et al.1993, Howie et al. 1998, Meding et al. 2000, Collis and Mohler 2002). The good long-term results of polished taper stems are probably attributable to the preservation of the proximal femoral cortex and such stems are associated with a low incidence of radiolucent lines in the proximal femur (Fowler et al. 1988, Wroblewski et al. 2001, Yates et al. 2002). Furthermore, using finite element analysis, it has been shown that polished prostheses give limited stem subsidence and cement creep (Verdonschot and Huiskes 1996, 1997, 1998, Lu and McKellop 1997, Norman et al. 2001), which may be beneficial. This suggests that stem subsidence without cement fracture observed in clinical practice, a phenomenon specific to polished taper stems (Fowler et al. 1988, Howie et al. 1998, Yates et al. 2002, Williams et al. 2002, Ek and Choong 2005), may be attributable to cement creep (Weightman et al. 1987). In a taper stem scenario, Lee (1990) hypothesized that the forces applied to the cement, to the cement-stem interface, and to the bone-cement interface may differ depending on the surface finish of the stem. The forces applied due to a rough stem are mainly tensile and shear forces, while for a polished stem they are mainly compressive. Assuming that this hypothesis is correct, these differences in the force applied to the cement and bone may explain the difference in clinical results for polished and rough stems. Lee''s theory has, however, not been studied using a mechanical model. It is difficult to perform a comparative study in cadavers since bone quality, bone shape, and femoral canal size vary—which may influence the results. Furthermore, the characteristics of cement can change as a result of changes in temperature and humidity (Lee et al. 1990, Arnold and Venditti 2001). For this study, we used an in vitro simulated cemented hip replacement model to quantify the difference in stem subsidence of polished and rough surface-finished taper stems into the cement and to determine whether the surface finish has an influence on the mechanical effects of any differences in the cement.     

Measurement of early bone loss around an uncemented femoral stem

Background and purpose

Dual-energy X-ray absorptiometry (DXA) is a precise method to study changes in bone mineral density (BMD), including the pattern of bone remodeling around an implant. Results from implant studies are usually presented as changes in BMD as a function of time. The baseline and reference value for such calculations is the first measurement after the operation. The baseline measurement has been performed at different time points in different studies. If there is rapid bone loss immediately after an operation, this will influence the reference value and hence the results. To evaluate DXA as a method, we studied the very early changes by doing 3 DXA measurements within the first 2 weeks after surgery.

Patients and methods

We included 23 hips in 23 patients who were operated with an uncemented total hip prosthesis (THP). Each Gruen region was measured with DXA at 1, 5, and 14 days, and 3 and 12 months after the operation. 16 of the patients completed all 5 follow-ups.

Results

There was no detectable change in BMD in the first 14 days after the operation. In all zones, the lowest BMD was measured after 3 months.

Interpretation

We conclude that DXA measurements done within 14 days after the operation can be used as reference measurements for later follow-up studies.The bone remodeling around hip prostheses appears to vary a great deal with different fixation methods and stem designs (Kiratli et al. 1996, Boden et al. 2004, Rahmy et al. 2004, Grant et al. 2005). Even with the same implant, researchers have reported a variety of bone mineral density (BMD) changes. In implant research, BMD results are most often given in percentage change relative to the first postoperative measurement. The postoperative measurement is used as a reference to avoid measuring the changes in BMD due to the operation (Kroger et al. 1996). During surgery, bone is removed and compacted due to rasping and insertion of the stem. The reference measurement is of importance because it influences all later results. Aamodt (2004) presented 2-year dual-energy X-ray absorptiometry (DXA) results, with 23% bone loss in Gruen zone 7 for the ABG-1 stem. Van der Wal et al. (2008) reported 2 patient groups with 12% and 15% reduction in BMD in zone 7 for the same femoral stem. The only obvious difference in these 2 studies was the timing of the first measurement. Van der Wal performed the baseline measurement at 10 days postoperatively while Aamodt performed the first postoperative measurement 3–5 days after the operation. Rapid bone loss from day 3–5 to day 10 could therefore have explained the difference in bone loss at 2 years.It is not fully known whether the bone loss starts immediately after the operation or after a few weeks. In the early postoperative period, BMD might change because of disuse atrophy (McCarthy et al. 1991) or because of the trauma to the bone (Karlsson et al. 2000). We hypothesized there is a rapid bone loss in the first days after operation, which would be an important source of bias to postoperative reference measurements.     

Perioperative mortality after hemiarthroplasty related to fixation method

Background and purpose

The appropriate fixation method for hemiarthroplasty of the hip as it relates to implant survivorship and patient mortality is a matter of ongoing debate. We examined the influence of fixation method on revision rate and mortality.

Methods

We analyzed approximately 25,000 hemiarthroplasty cases from the AOA National Joint Replacement Registry. Deaths at 1 day, 1 week, 1 month, and 1 year were compared for all patients and among subgroups based on implant type.

Results

Patients treated with cemented monoblock hemiarthroplasty had a 1.7-times higher day-1 mortality compared to uncemented monoblock components (p < 0.001). This finding was reversed by 1 week, 1 month, and 1 year after surgery (p < 0.001). Modular hemiarthroplasties did not reveal a difference in mortality between fixation methods at any time point.

Interpretation

This study shows lower (or similar) overall mortality with cemented hemiarthroplasty of the hip.The frequency of hip fractures is increasing with our ageing population, with an annual incidence of between 1.4 and 5 per 103 per year (Lonnroos et al. 2006, Icks et al. 2008, Varez-Nebreda et al. 2008). Health model projections have estimated that 6.3 million hip fractures will occur annually worldwide within the next 40 years (Cooper et al. 1992), imposing a significant economic health burden. There is a large reported perioperative mortality rate in this population, ranging from 2.4% to 8.2% at 1 month (Parvizi et al. 2001, Radcliff et al. 2008) and over 25% at 1 year (Elliott et al. 2003, Jiang et al. 2005). Furthermore, it was recently reported that the current mortality rate is higher now than 25 years ago (Vestergaard et al. 2007a). Today, it is generally accepted that displaced intracapsular fractures are best treated with arthroplasty rather than internal fixation (Keating et al. 2006, Leighton et al. 2007). In the at-risk population, however, multiple comorbidities are common and the best form of component fixation is in question.Bone cement implantation syndrome is a well-described complication of cemented hip arthroplasty. It is characterized by a systemic drop in systolic blood pressure, hypoxemia, pulmonary hypertension, cardiac dysrhythmias, and occasionally cardiac arrest and death (Rinecker 1980, Orsini et al. 1987, Parvizi et al. 1999). The prevailing theory to explain the pathophysiology of this phenomenon is embolism of fat, marrow contents, bone, and to some degree methylmethacrylate to the lung (Rinecker 1980, Elmaraghy et al. 1998, Parvizi et al. 1999, Koessler et al. 2001). An increased degree of pulmonary insult with fat microemboli has been demonstrated (mostly in randomized controlled trials) during insertion of a cemented femoral stem rather than an uncemented implant (Orsini et al. 1987, Ries et al. 1993, Christie et al. 1994, Pitto et al. 1999), presumably due to increased intramedullary femoral canal pressures in the cemented group (Kallos et al. 1974, Orsini et al. 1987). These pressures can be reduced by the use of distal venting holes in the femur during stem insertion (Engesæter et al. 1984). It has been shown previously by single-institutional review that patients undergoing cemented hip arthroplasty have a higher intraoperative mortality rate relative to uncemented arthroplasty, presumably due to a reduced incidence of fat embolism in the latter group (Parvizi et al. 1999). The increased mortality risk was also present at 30 days in the treatment of acute fractures with cemented arthroplasty, also from a single-institutional review (Parvizi et al. 2004). Although cement-related mortality is rare (Dearborn and Harris 1998, Parvizi et al. 1999, 2001, 2004, Weinrauch et al. 2006), it is a devastating complication—often reported through observational studies or literature reviews. Proponents of uncemented hip arthroplasty often cite this concern to support their reluctance to use cemented hip arthroplasty in both elective procedures and fracture management. However, many different types of studies have been unable to identify any increased mortality risk with the use of cement (Lausten and Vedel 1982 (observational), Emery et al. 1991 (RCT), Lo et al. 1994 (observational), Khan et al. 2002a,b (literature review), Parker and Gurusamy 2004 (literature review)) and others have shown a decrease in mortality at 30 days when cement is used (Foster et al. 2005).Cemented hip hemiarthroplasty appears to offer improved rate of return to baseline function, reduced postoperative pain, and superior long-term survivorship relative to uncemented arthroplasty (Khan et al. 2002a, b, Parker and Gurusamy 2004). We reasoned that failure to return to baseline function after hemiarthroplasty may be another risk factor for perioperative mortality (Hannan et al. 2001, Braithwaite et al. 2003). Lower revision rates for cemented prostheses and increased mortality at revision surgery contribute further to reducing the overall mortality risk. We evaluated the relationship between the method of fixation of hip arthroplasty and perioperative mortality using a large national joint replacement registry.     

Intraarticular location predicts cartilage filling and subchondral bone changes in a chondral defect

Background and purpose

The natural history of, and predictive factors for outcome of cartilage restoration in chondral defects are poorly understood. We investigated the natural history of cartilage filling subchondral bone changes, comparing defects at two locations in the rabbit knee.

Animals and methods

In New Zealand rabbits aged 22 weeks, a 4-mm pure chondral defect (ICRS grade 3b) was created in the patella of one knee and in the medial femoral condyle of the other. A stereo microscope was used to optimize the preparation of the defects. The animals were killed 12, 24, and 36 weeks after surgery. Defect filling and the density of subchondral mineralized tissue was estimated using Analysis Pro software on micrographed histological sections.

Results

The mean filling of the patellar defects was more than twice that of the medial femoral condylar defects at 24 and 36 weeks of follow-up. There was a statistically significant increase in filling from 24 to 36 weeks after surgery at both locations.The density of subchondral mineralized tissue beneath the defects subsided with time in the patellas, in contrast to the density in the medial femoral condyles, which remained unchanged.

Interpretation

The intraarticular location is a predictive factor for spontaneous filling and subchondral bone changes of chondral defects corresponding to ICRS grade 3b. Disregarding location, the spontaneous filling increased with long-term follow-up. This should be considered when evaluating aspects of cartilage restoration.Focal articular cartilage injuries of the knee are common (Hjelle et al. 2002, Aroen et al. 2004) and they can impair patients'' quality of life as much as severe osteoarthritis (Heir et al. 2010). The literature concerning the natural history of focal cartilage defects in patients, and the intrinsic factors affecting it, is limited (Linden 1977, Messner and Gillquist 1996, Drogset and Grontvedt 2002, Shelbourne et al. 2003, Loken et al. 2010). In experimental studies evaluating cartilage restoration in general, the importance of intrinsic factors such as the depth and size of the lesion and the time from when the lesion was made to evaluation have been emphasized (Shapiro et al. 1993, Hunziker 1999, Lietman et al. 2002). Which part of the joint is affected and whether or not the defect is weight-bearing are also of interest (Hurtig 1988, Frisbie et al. 1999). Most of these studies have, however, concerned defects penetrating the subchondral mineralized tissues corresponding to ICRS grade 4 (Brittberg and Winalski 2003). Access to bone marrow elements in these defects might be one of the strongest predictive factors for filling of the defect, making the importance of other factors difficult to evaluate (Hunziker 1999).In experimental studies on pure chondral defects that do not penetrate the subchondral mineralized tissues, corresponding to ICRS grade 3b (Brittberg and Winalski 2003), the type of animal studied, the size of the lesion, and the location of the defects vary, and there is limited data on the influence of these parameters on outcome (Breinan et al. 2000). The information on spontaneous filling comes mainly from observations of untreated defects serving as controls (Grande et al. 1989, Brittberg et al. 1996, Breinan et al. 1997, 2000, Frisbie et al. 1999, 2003, Dorotka et al. 2005) and the information on subchondral bone changes is even more limited (Breinan et al. 1997, Frisbie et al. 1999). Although most human focal cartilage lesions are located on the medial femur condyle (Aroen et al. 2004), there have been few experimental studies involving untreated ICRS grade 3b defects on the medial femur condyle (Dorotka et al. 2005). According to a PubMed search, the rabbit knee is the most widely used experimental animal model for cartilage restoration (Årøen 2005). The locations of ICRS grade 3 chondral defects in the rabbit knee evaluated for spontaneous changes have included the patella (Grande et al. 1989, Brittberg et al. 1996) and, in one study, defects at the distal surface of the femur (Mitchell and Shepard 1976). The latter report did not, however, include quantitative data.To our knowledge, the influence of the intraarticular location on the outcome of cartilage restoration and subchondral bone changes has not been thoroughly studied. Thus, the main purpose of our study was to test the hypothesis that the intraarticular location influences the spontaneous filling of a chondral defect that does not penetrate the subchondral bone. Secondly, we wanted to evaluate whether the intraarticular location would influence changes in the subchondral bone and degenerative changes as evaluated from macroscopic appearance and proteoglycan content of synovial fluid (Messner et al. 1993a).     

Effects of hydroxyapatite coating on survival of an uncemented femoral stem. A Swedish Hip Arthroplasty Register study on 4,772 hips

Background and purpose

Hydroxyapatite (HA) is widely used as a coating for uncemented total hip arthroplasty components. This has been suggested to improve implant ingrowth and long-term stability. However, the evidence behind the use of HA coating on femoral stems is ambiguous. We investigated survival of an uncemented, tapered titanium femoral stem that was available either with or without HA coating (Bi-Metric).

Patients and methods

The stem had been used in 4,772 total hip arthroplasties (THAs) in 4,169 patients registered in the Swedish Hip Arthroplasty Register between 1992 and 2009. 59% of the stems investigated were coated with HA and 41% were uncoated. Kaplan-Meier survival analysis and a Cox regression model with adjustment for age, sex, primary diagnosis, and the type of cup fixation were used to calculate survival rates and adjusted risk ratios (RRs) of the risk of revision for various reasons.

Results

The 10-year survival rates of the HA-coated version and the uncoated version were about equal when we used revision for any reason as the endpoint: 98% (95% CI: 98–99) and 98% (CI: 97–99), respectively. A Cox regression model adjusting for the covariates mentioned above showed that the presence of HA coating did not have any influence on the risk of stem revision for any reason (RR = 1.0, 95% CI: 0.6–1.6) or due to aseptic loosening (RR = 0.5, CI: 0.2–1.5). There was no effect of HA coating on the risk of stem revision due to infection, dislocation, or fracture.

Interpretation

The uncemented Bi-Metric stem showed excellent 10-year survival. Our findings do not support the use of HA coating on this stem to enhance implant survival.It is generally believed that coating of total hip arthroplasty (THA) components with hydroxyapatite (HA) improves implant ingrowth and long-term stability. Thus, a large number of prostheses designed for uncemented hip arthroplasty are coated with HA. In Europe, some manufacturers mainly or exclusively market uncemented hip prostheses with such a coating.The evidence behind the use of HA is ambiguous, however. Several reports on smaller series have described varying outcomes after the use of HA-coated cups or stems. Good or even excellent results were found after the use of some HA-coated implants, with survival rates close to 100% when using revision or impending revision for aseptic loosening as the endpoint (Oosterbos et al. 2001, Capello et al. 2003, Shah et al. 2009). On the other hand, mediocre to obviously inferior results of HA-coated hip arthroplasty components have also been reported (Havelin et al. 2000, Reikerås and Gunderson 2002, Cheung et al. 2005, Kim et al. 2006). A large Danish registry analysis on uncemented hip implants found that HA coating did not reduce the risk of revision in patients younger than 70 years of age (Paulsen et al. 2007). In a recent analysis based on data from the Swedish Hip Arthroplasty Register, we found that HA coating of acetabular cups could even increase the risk of revision due to aseptic loosening (Lazarinis et al. 2010).In this study, we analyzed survival of uncemented femoral stems in the Swedish Hip Arthroplasty Register that were used either with or without HA coating. Our main hypothesis was that HA coating influences the risk of stem revision for any reason, which was our primary endpoint. Secondary endpoints were stem revision due to aseptic loosening, infection, fracture, or dislocation.     

Locking plate osteosynthesis in displaced 4-part fractures of the proximal humerus

Background and purpose

There is considerable uncertainty about the optimal treatment of displaced 4-part fractures of the proximal humerus. Within the last decade, locking plate technology has been considered a breakthrough in the treatment of these complex injuries.

Methods

We systematically identified and reviewed clinical studies on the benefits and harms after osteosynthesis with locking plates in displaced 4-part fractures.

Results

We included 14 studies with 374 four-part fractures. There were 10 case series, 3 retrospective observational comparative studies, 1 prospective observational comparative study, and no randomized trials. Small studies with a high risk of bias precluded reliable estimates of functional outcome. High rates of complications (16–64%) and reoperations (11–27%) were reported.

Interpretation

The empirical foundation for the value of locking plates in displaced 4-part fractures of the proximal humerus is weak. We emphasize the need for well-conducted randomized trials and observational studies.There is considerable uncertainty about the optimal treatment of displaced 4-part fractures of the proximal humerus (Misra et al. 2001, Handoll et al. 2003, Bhandari et al. 2004, Lanting et al. 2008). Only 2 small inconclusive randomized trials have been published (Stableforth 1984, Hoellen et al. 1997). A large number of interventions are used routinely, ranging from a non-operative approach to open reduction and internal fixation (ORIF), and primary hemiarthroplasty (HA).In the last decade, locking plate technology has been developed and has been heralded as a breakthrough in the treatment of fractures in osteoporotic bone (Gautier and Sommer 2003, Sommer et al. 2003, Haidukewych 2004, Miranda 2007). Locking plate technique is based on the elimination of friction between the plate and cortex, and relies on stability between the subchondral bone and screws. Multiple multidirectional convergent and divergent locking screws enhance the angular stability of the osteosynthesis, possibly resulting in better postoperative function with reduced pain. Reported complications include screw cut-out, varus fracture collapse, tuberosity re-displacement, humeral head necrosis, plate impingement, and plate or screw breakage (Hall et al. 2006, Tolat et al. 2006, van Rooyen et al. 2006, Agudelo et al. 2007, Gardner et al. 2007, Khunda et al. 2007, Ring 2007, Smith et al. 2007, Voigt et al. 2007, Egol et al. 2008, Kirchhoff et al. 2008, Owsley and Gorczyca 2008, Brunner et al. 2009, Micic et al. 2009, Sudkamp et al. 2009). The balance between the benefit and harms of the intervention seems delicate.Several authors of narrative reviews and clinical series have strongly recommended fixation of displaced 4-part fractures of the humerus with locking plates (Bjorkenheim et al. 2004, Hente et al. 2004, Hessler et al. 2006, Koukakis et al. 2006, Kilic et al. 2008, Korkmaz et al. 2008, Shahid et al. 2008, Papadopoulos et al. 2009, Ricchetti et al. 2009) and producers of implants unsurprisingly strongly advocate them (aap Implantate 2010, Stryker 2010, Synthes 2010, Zimmer 2010). Despite the increasing use of locking plates (Illert et al. 2008, Ricchetti et al. 2009), we have been unable to identify systematic reviews on the benefits and harms of this new technology in displaced 4-part fractures. Thus, we systematically identified and reviewed clinical studies on the benefits and harms after osteosynthesis with locking plates in displaced 4-part fractures of the proximal humerus.     

No clinical benefit of gender-specific total knee arthroplasty: A systematic review and meta-analysis of 6 randomized controlled trials

Background and purpose

There is no consensus regarding the clinical relevance of gender-specific prostheses in total knee arthroplasty (TKA). We summarize the current best evidence in a comparison of clinical and radiographic outcomes between gender-specific prostheses and standard unisex prostheses in female patients.

Methods

We used the PubMed, Embase, Cochrane, Science Citation Index, and Scopus databases. We included randomized controlled trials published up to January 2013 that compared gender-specific prostheses with standard unisex prostheses in female patients who underwent primary TKAs.

Results

6 trials involving 423 patients with 846 knee joints met the inclusion criteria. No statistically significant differences were observed between the 2 designs regarding pain, range of motion (ROM), knee scores, satisfaction, preference, complications, and radiographic results. The gender-specific design (Gender Solutions; Zimmer Inc, Warsaw, Indiana) reduced the prevalence of overhang. However, it had less overall coverage of the femoral condyles compared to the unisex group. In fact, the femoral prosthesis in the standard unisex group matched better than that in the gender-specific group.

Interpretation

Gender-specific prostheses do not appear to confer any benefit in terms of clinician- and patient-reported outcomes for the female knee.Women account for almost two-thirds of knee arthroplasties (Kurtz et al. 2007). Recently, a possible effect of gender on functional outcomes and implant survivorship has been identified (Vincent et al. 2006, Ritter et al. 2008, Kamath et al. 2010, Parsley et al. 2010, O’Connor 2011). Gender differences in the anatomy of the distal femur are well documented (Conley et al. 2007, Yue et al. 2011a, b, Yan et al. 2012, Zeng et al. 2012). Women tend to have a less prominent anterior condyle (Conley et al. 2007, Fehring et al. 2009), a higher quadriceps angle (Q-angle) (Hsu et al. 1990, Woodland et al. 1992), and a reduced mediolateral to anteroposterior aspect ratio (Chin et al. 2002, Chaichankul et al. 2011). Investigators have found that standard unisex knee prostheses may not equally match the native anatomy in male and female knees (Clarke and Hentz 2008, Yan et al. 2012). A positive association between the femoral component size and the amount of overhang was observed in females, and femoral component overhang (≥ 3 mm) may result in postoperative knee pain or reduced ROM (Hitt et al. 2003, Lo et al. 2003, Mahoney et al. 2010).The concept of gender-specific knee prostheses was introduced to match these 3 anatomic differences in the female population (Conley et al. 2007). It includes a narrower mediolateral diameter for a given anteroposterior dimension, to match the female knee more closely. Additionally, the anterior flange of the prothesis was modified to include a recessed patellar sulcus and reduced anterior condylar height (to ovoid “overstuffing” during knee flexion) and a lateralized patellar sulcus (to accommodate the increased Q-angle associated with a wider pelvis).Several randomized controlled trials (RCTs) have failed to establish the superiority of the gender-specific prosthesis over the unisex knee prosthesis in the female knee (Kim et al. 2010a, b, Song et al. 2012a, Thomsen et al. 2012, von Roth et al. 2013). In contrast, other studies have found higher patient satisfaction and better radiographic fit in the gender-specific TKAs than in the standard unisex TKAs (Clarke and Hentz 2008, Parratte et al. 2011, Yue et al. 2014). We therefore performed a systematic review and meta-analysis to compare the clinical and radiographic results of TKA in female patients receiving gender-specific prostheses or standard unisex prostheses.     

No effect of risedronate on femoral periprosthetic bone loss following total hip arthroplasty: A 4-year follow-up of 61 patients in a double-blind,randomized placebo-controlled trial

Background and purpose

We have previously shown that during the first 2 years after total hip arthroplasty (THA), periprosthetic bone resorption can be prevented by 6 months of risedronate therapy. This follow-up study investigated this effect at 4 years.

Patients and methods

A single-center, double-blind, randomized placebo-controlled trial was carried out from 2006 to 2010 in 73 patients with osteoarthritis of the hip who were scheduled to undergo THA. The patients were randomly assigned to receive either 35 mg risedronate or placebo orally, once a week, for 6 months postoperatively. The primary outcome was the percentage change in bone mineral density (BMD) in Gruen zones 1 and 7 in the proximal part of the femur at follow-up. Secondary outcomes included migration of the femoral stem and clinical outcome scores.

Results

61 of the 73 patients participated in this 4-year (3.9- to 4.1-year) follow-up study. BMD was similar in the risedronate group (n = 30) and the placebo group (n = 31). The mean difference was −1.8% in zone 1 and 0.5% in zone 7. Migration of the femoral stem, the clinical outcome, and the frequency of adverse events were similar in the 2 groups.

Interpretation

Although risedronate prevents periprosthetic bone loss postoperatively, a decrease in periprosthetic BMD accelerates when therapy is discontinued, and no effect is seen at 4 years. We do not recommend the use of risedronate following THA for osteoarthritis of the hip.Adaptive bone remodeling around the femoral stem following total hip arthroplasty (THA) results in regional loss of bone mass, especially in proximal parts of the femur—most of which takes place within the first postoperative year (Bodén et al. 2006, Sköldenberg et al. 2006). Periprosthetic bone loss may predispose to periprosthetic fracture, aseptic loosening, and difficulties at revision surgery (Lindahl 2007, Streit et al. 2011, Sköldenberg et al. 2014).The bisphosphonate (BP) risedronate has been used successfully to prevent osteoporotic fractures, mainly in the hip and vertebrae, by inhibiting osteoclast activity (McClung et al. 2001). In recent years, the possible use of BPs to prevent or ameliorate periprosthetic adaptive bone resorption, osteolysis, and implant migration has been investigated thoroughly in animal models and humans. The short-term results of several studies showing the effects of postoperative BP treatment in reducing periprosthetic bone loss up to a year after the arthroplasty have already been published (Venesmaa et al. 2001, Wilkinson et al. 2001, Hennigs et al. 2002, Wilkinson et al. 2005, Arabmotlagh et al. 2006).We have previously found that risedronate given once a week for 6 months after THA reduces periprosthetic bone resorption around an uncemented femoral stem in the first and second postoperative year (Sköldenberg et al. 2011). We now report the 4-year outcome in the same cohort.     

More accurate component alignment in navigated total knee arthroplasty has no clinical benefit at 5-year follow-up

Background and purpose

Computer navigation in total knee arthroplasty is somewhat controversial. We have previously shown that femoral component positioning is more accurate with computed navigation than with conventional implantation techniques, but the clinical impact of this is unknown. We now report the 5-year outcome of our previously reported 2-year outcome study.

Methods

78 of initially 84 patients (80 of 86 knees) were clinically and radiographically reassessed 5 (5.1–5.9) years after conventional, image-based, and image-free total knee arthroplasty. The methodology was identical to that used preoperatively and at 2 years, including the Knee Society score (KSS) and the functional score (FS), and AP and true lateral standard radiographs.

Results

Although a more accurate femoral component positioning in the navigated groups was obtained, clinical outcome, number of reoperations, KSS, FS, and range of motion were similar between the groups.

Interpretation

The increased costs and time for navigated techniques did not translate into better functional and subjective medium-term outcome compared to conventional techniques.Abnormal wear patterns and component loosening are mainly results of component malalignment and complications of the extensor mechanism, the most common reasons for early failure of TKA (Ritter et al. 1994, Rand et al. 2003, Vince 2003, Bathis et al. 2004). It has been suggested that a varus or valgus malalignment of more the 3° leads to faster wear and debris, followed by early failure of TKA (Ecker et al. 1987, Archibeck and White 2003, Nizard et al. 2004).Several surgical navigation systems for TKA have been introduced to optimize component positioning (Delp et al. 1998, DiGioia et al. 1998, Krackow et al. 1999). It has been shown that navigation provides a more precise component positioning and fewer outliers (Bathis et al. 2004, Nabeyama et al. 2004, Stockl et al. 2004, Victor and Hoste 2004, Anderson et al. 2005, Zumstein et al. 2006). Nevertheless, comparing computer-navigated total knee arthroplasty with conventional implantation techniques, there is no evidence in the current literature of any significant improvement in clinical outcome and in component loosening (Bathis et al. 2004, Jenny et al. 2005, Yau et al. 2005, Bonutti et al. 2008, Molfetta and Caldo 2008).In a prospective study involving 86 patients in 3 different groups (image-based navigation, image-free navigation, and conventional), we showed that femoral component positioning was more accurate with navigation than with conventional implantation techniques, but tibial positioning showed similar results (Zumstein et al. 2006).Although other medium-term data on navigated total knee arthroplasty have already been reported (Ishida et al. 2011, Schmitt et al. 2011), there has been no prospective cohort series with reporting of the clinical, functional, and radiographic outcome with all 3 techniques: image-based navigated, image-free navigated, or conventional TKA. We therefore determined the clinical, functional, and radiographic 5-year results after each of the 3 techniques.     

Fixation of the fully hydroxyapatite-coated Corail stem implanted due to femoral neck fracture: 38 patients followed for 2 years with RSA and DEXA

Background

Today, dislocated femoral neck fractures are commonly treated with a cemented hip arthroplasty. However, cementing of the femoral component may lead to adverse effects and even death. Uncemented stems may lower these risks and hydroxyapatite (HA) coating may enhance integration, but prosthetic stability and clinical outcome in patients with osteoporotic bone have not been fully explored. We therefore studied fixation and clinical outcome in patients who had had a femoral neck fracture and who had received a fully HA-coated stem prosthesis.

Patients and methods

50 patients with a dislocated femoral neck fracture were operated with the fully HA-coated Corail total or hemiarthroplasty. 38 patients, mean age 81 (70–96) years, were followed for 24 months with conventional radiographs, RSA, DEXA, and for clinical outcome.

Results

31 of the 38 implants moved statistically significantly up to 3 months, mainly distally, mean 2.7 mm (max. 20 mm (SD 4.3)), and rotated into retroversion mean 3.3º (–1.8 to 17) (SD 4.3) and then appeared to stabilize. Distal stem migration was more pronounced if the stem was deemed to be too small. There was no correlation between BMD and stem migration. The migration did not result in any clinically adverse effects.

Interpretation

The fully hydroxyapatite-coated Corail stem migrates during the first 3 months, but clinical outcome appears to be good, without any adverse events.Several studies have indicated that fractures that are dislocated in patients who are more than 65–70 years old are best treated with hemi- or total hip arthroplasty. In large patient materials, an increase in mortality rate has been observed during the first year for cemented arthroplasties relative to uncemented arthroplasties (Khan et al. 2002, Rogmark et al. 2002, Parker and Gurusamy 2004). Embolization of fat, bone marrow, and cement particles is thought to contribute to this (Christie et al. 1995, Elmaraghy et al. 1998, Clark et al. 2001, Riding et al. 2004, Panesar et al. 2009). There are, however, concerns regarding the fixation of the uncemented stem to the osteoporotic bone. We therefore studied the migration pattern in relation to bone mineral density and size and position of the uncemented, fully hydroxyapatite coated Corail stem in patients with dislocated femoral neck fractures.     

No adverse effects of submelt-annealed highly crosslinked polyethylene in cemented cups: an RSA study of 8 patients 10 yaers after surgery

Background and purpose

Highly crosslinked polyethylene (PE) is in standard use worldwide. Differences in the crosslinking procedure may affect the clinical performance. Experimenatal data from retrieved cups have shown free radicals and excessive wear of annealed highly crosslinked PE. We have previously reported low wear and good clinical performance after 6 years with this implant, and now report on the 10-year results.

Patients and methods

In 8 patients, we measured wear of annealed highly crosslinked PE prospectively with radiostereometry after 10 years. Activity was assessed by UCLA activity score and a specifically designed activity score. Conventional radiographs were evaluated for osteolysis and clinical outcome by the Harris hip score (HHS).

Results

The mean (95% CI) proximal head penetration for highly crosslinked PE after 10 years was 0.07 (–0.015 to 0.153) mm, and the 3D wear was 0.2 (0.026 to 0.36) mm. Without creep, proximal head penetration was 0.02 (–0.026 to 0.066) mm and for 3D penetration was 0.016 (–0.47 to 0.08) mm. This represents an annual proximal wear of less than 2 µm. All cups were clinically and radiographically stable but showed a tendency of increased rotation after 5 years.

Interpretation

Wear for annealed highly crosslinked PE is extremely low up to 10 years. Free radicals do not affect mechanical performance or lead to clinically adverse effects. Creep stops after the first 6 months after implantation. Highly crosslinked PE is a true competitor of hard-on-hard bearings.Highly crosslinked polyethylene (PE) has become a standard option in acetabular cups. Long-term results are still not available, since modern highly crosslinked PE (HXLPE) was introduced into the market around the shift of the millennium (Thomas et al. 2011). Fuelled by the debate about degradation through free radicals (Currier et al. 2007) and preservation of mechanical properties (Tower et al. 2007), there are at least 9 different highly crosslinked PEs with different production protocols commercially available. Although early pilot studies with HXLPE (Oonishi et al. 1998, Grobbelar et al. 1999. Wroblewski et al. 1999) with annealed or remelt-stabilized PE have shown good clinical results, modern first-generation HXLPE was introduced by McKellop (1999) and by Kurtz et al. (1999) in the late 1990s. Since then, second-generation HXLPE with either additives (vitamin E), mechanical enhancement (Kurtz et al. 2006a), or a sequential annealing process have been introduced and promise further improvement. Although HXLPE is in clinical use globally, little is known about the oxidative in vivo stability of these new polyethylenes (Muratoglu et al. 2010).Concerns with annealed (non-remelted) HXLPE are free radicals trapped in the matrix, leading to degradation and excessive wear (Kurtz et al. 2006b, 2011). However, this is not supported by clinical data. So far, it appears that HXLPE reduces the risk of osteolysis (Digas et al. 2007, Jacobs et al. 2007, Callaghan et al. 2008, Kurtz et al. 2011). At the same time, alarming results with increased wear have been reported with remelted HXLPE from retrievals (Muratoglu et al. 2010).We therefore measured femoral head penetration in a cohort with annealed first-generation highly crosslinked polyethylene with radiostereometry. Femoral head penetration is a substitute for in vivo wear measurement (Valstar et al. 2005, Bragdon et al. 2006). We consider it important to report on the 10-year wear measurement for 5 reasons: (1) we used RSA, a high-precision measuring method (Valstar et al. 2005), (2) retrieval studies have shown increased degradation of this HXLPE from oxidation (Currier et al 2007), (3) other HXLPEs have shown increasing wear after 5 years, (4) serum protein may influence wear performance negatively in the long term (St. John 2009), and (5) HXLPE is the most commonly used bearing material in THA worldwide. We therefore update our previous 6-year report on submelt-annealed crosslinked PE (Röhrl et al. 2005, 2007) with 10-year data on wear and clinical outcome.     

Maximum temperatures of 89°C recorded during the mechanical preparation of 35 femoral heads for resurfacing

Background and purpose

We noticed that our instruments were often too hot to touch after preparing the femoral head for resurfacing, and questioned whether the heat generated could exceed temperatures known to cause osteonecrosis.

Patients and methods

Using an infra-red thermal imaging camera, we measured real-time femoral head temperatures during femoral head reaming in 35 patients undergoing resurfacing hip arthroplasty. 7 patients received an ASR, 8 received a Cormet, and 20 received a Birmingham resurfacing arthroplasty.

Results

The maximum temperature recorded was 89°C. The temperature exceeded 47°C in 28 patients and 70°C in 11. The mean duration of most stages of head preparation was less than 1 min. The mean time exceeded 1 min only on peripheral head reaming of the ASR system. At temperatures lower than 47°C, only 2 femoral heads were exposed long enough to cause osteonecrosis. The highest mean maximum temperatures recorded were 54°C when the proximal femoral head was resected with an oscillating saw and 47°C during peripheral reaming with the crown drill. The modified new Birmingham resurfacing proximal femoral head reamer substantially reduced the maximum temperatures generated. Lavage reduced temperatures to a mean of 18°C.

Interpretation

11 patients were subjected to temperatures sufficient to cause osteonecrosis secondary to thermal insult, regardless of the duration of reaming. In 2 cases only, the length of reaming was long enough to induce damage at lower temperatures. Lavage and sharp instruments should reduce the risk of thermal insult during hip resurfacing.Hip resurfacing can fail due to osteonecrosis (Amstutz et al. 2004, Daniel et al. 2004). Osteonecrosis has been explored by surrogate means. The femoral head is devascularized by the posterior approach (Steffen et al. 2005, Beaule et al. 2006, Khan et al. 2007) and its blood flow is reduced by 50% if the neck is notched (Beaule et al. 2006). Temperatures during femoral head preparation are unknown and could be a cause of osteonecrosis. Temperatures may reach 68°C when cement is polymerizing during resurfacing (Gill et al. 2007).The effect of heat generated in bone at the cellular level is difficult to quantify. The important factors are the peak temperature and the duration of the thermal insult. With higher temperatures, a shorter exposure is needed to cause injury (Lundskog 1972, Berman et al. 1984). Thermal insult of 47°C for 60 s is the threshold for bone injury (Ericksson and Albrektsson 1983). Exposure to 50°C for 30 s causes widespread injury to bone 1 mm from the point of exposure (Lundskog 1972) and 55°C for 1 min causes marrow necrosis (Berman et al. 1984). Bone alkaline phosphatase is denatured at 56°C (Posen et al. 1965). When bone reaches to a temperature of 70°C or more, macroscopic bone necrosis can be seen intraoperatively. Cell necrosis occurs at temperatures of 70°C within 1 s (Moritz and Henriques 1947). There is histological evidence of bone necrosis after exposure to 70°C for 1 min (Berman et al. 1984) and 80°C for 5 s (Lundskog 1972).We noticed that our instruments were often too hot to touch after preparing the femoral head for resurfacing and wondered whether the heat generated during femoral head preparation might exceed the temperatures known to cause osteonecrosis.     

A randomized study on migration of the Spectron EF and the Charnley flanged 40 cemented femoral components using radiostereometric analysis at 2 years

Background and purpose

We performed a randomized study to determine the migration patterns of the Spectron EF femoral stem and to compare them with those of the Charnley stem, which is regarded by many as the gold standard for comparison of implants due to its extensive documentation.

Patients and methods

150 patients with a mean age of 70 years were randomized, single-blinded, to receive either a cemented Charnley flanged 40 monoblock, stainless steel, vaquasheen surface femoral stem with a 22.2-mm head (n = 30) or a cemented Spectron EF modular, matte, straight, collared, cobalt-chrome femoral stem with a 28-mm femoral head and a roughened proximal third of the stem (n = 120). The patients were followed with repeated radiostereometric analysis for 2 years to assess migration.

Results

At 2 years, stem retroversion was 2.3° and 0.7° (p < 0.001) and posterior translation was 0.44 mm and 0.17 mm (p = 0.002) for the Charnley group (n = 26) and the Spectron EF group (n = 74), respectively. Subsidence was 0.26 mm for the Charnley and 0.20 mm for the Spectron EF (p = 0.5).

Interpretation

The Spectron EF femoral stem was more stable than the Charnley flanged 40 stem in our study when evaluated at 2 years. In a report from the Norwegian arthroplasty register, the Spectron EF stem had a higher revision rate due to aseptic loosening beyond 5 years than the Charnley. Initial stability is not invariably related to good long-term results. Our results emphasize the importance of prospective long-term follow-up of prosthetic implants in clinical trials and national registries and a stepwise introduction of implants.Femoral stem loosening in cemented total hip arthroplasty (THA) is a multifactorial process with different mechanisms (Gruen et al. 1979, Barrack 2000). Factors such as the material, design, and surface finish are of fundamental importance for the long-term performance of cemented femoral hip implants (Scheerlinck and Casteleyn 2006). The longevity of cemented femoral stems has been related to the quality, stability, and endurance of the bonding between stem and cement (Chang et al. 1998, Scheerlinck and Casteleyn 2006). Different femoral stem designs have been developed to obtain increased fixation at this interface, since debonding between the cement and stem is an important mechanism in the initiation of loosening (Jasty et al. 1991).The satin-finish Spectron femoral stem has been one of the best performing stems in the Swedish National Arthroplasty Register (Malchau et al. 2002). A modified, proximally roughened version of the Spectron stem, the Spectron EF (Smith and Nephew, Memphis, TN), was introduced in 1989 to enhance stem-cement bonding.The use of this implant gained increasing popularity, and in 2007 the Spectron EF stem used with the Reflection All-Poly acetabular cup (Smith and Nephew) was the most commonly used primary total hip prosthesis in Norway (Espehaug et al. 2009).The degree of migration during the first years after surgery has been shown to correlate with the long-term performance of joint prostheses (Kärrholm et al. 1994, Kobayashi et al. 1997). Radiostereometric analysis (RSA) allows the accurate measurement of implant movement and has been extensively used for measurement of the in vivo migration of implants (Kärrholm et al. 1997).An earlier prospective randomized study reported an increased revision rate of the Charnley stem compared to the satin-finished Spectron stem (Garellick et al. 1999). In the present randomized, controlled clinical trial we wanted to evaluate the early migration of the successor to this stem, the Spectron EF stem and to compare it to that of the Charnley stem using RSA. The null hypothesis was that the migration of the Spectron EF stem was equal to that of the Charnley prosthesis (DePuy International Ltd., Leeds, UK), which has the longest follow-up and the largest volume of documentation of implants used for primary total hip arthroplasty (Aamodt et al. 2004).     

Risk of periprosthetic femur fracture after anterior cortical bone windowing: a mechanical analysis of short versus long cemented stems in pigs

Background and purpose

Removal of distal cement at femoral implant revision is technically challenging and is associated with complications such as cortical perforations. A technique that can reduce the risks and operating time is to make a small cortical window in the distal femur for enhanced access. We wanted to determine whether the use of long, bridging, cemented femoral stems is necessary to reduce the risk of postoperative periprosthetic fractures after using an anterior cortical bone window.

Methods

66 fresh pig femurs underwent mechanical testing. Steel rods were implanted at 3 locations: (1) at the distal window edge, (2) 15 mm proximally to the cortical window edge, and (3) 15 mm distally. 54 femurs were tested using a 3-point bending setup and 12 femurs were tested using a torsional load setup.

Results

Load to fracture ratio and bending stiffness ratio were similar in the 3 groups, for either the 3-point bending test or the torsional load test.

Interpretation

Our findings suggest that bypass of cortical windows with a revision femoral component may not reduce the risk of periprosthetic fracture.The removal of well-fixed cement is difficult and time consuming. Various surgical techniques and instruments have been developed to facilitate cement removal: extended trochanteric osteotomy (Paprosky et al. 2001), cortical windows (Nelson and Weber 1981), cement removal osteotomes/gauges/reamers (Gray 1992), and ultrasound probes (Goldberg et al. 2007). Iatrogenic femoral host bone loss, inadvertent perforation, and femoral fracture are the main risks associated with the removal of cement (Klein and Rubash 1993).The use of cortical windows, as initially described by Nelson and Weber (1981), reduces the risk of perforation at the revision surgery, while allowing for full weight bearing. The window is typically made near the tip of the implant to facilitate distal cement removal (Moreland et al. 1986, Zweymuller et al. 2005). After removing the cement, the femur is prepared to receive the revision implant. The cortical lid, which has been removed in creating the window, is replaced and secured using a cerclage wire. The femoral prosthesis can then be inserted using standard techniques. Although the risk of perforation is less with the use of a cortical window, the risk of periprosthetic fracture remains. The risk of fracture is related to the size of the window (Panjabi et al. 1985, Larson et al. 1991). Concerns about periprosthetic fractures have led to the recommendation that the cortical window should be bypassed by 2 cortical diameters, by the femoral prosthesis (Dennis et al. 1987, Larson et al. 1991, Klein and Rubash 1993). The rule of two cortical diameters is based on a finite element model by Dennis et al. (1987). There is very little biomechanical data to support this practice. Larson and associates (Larson et al. 1991) published a mechanical study on bypassing cortical defects on canine cadavers. The size of the cortical defect used in their experiment was 50% of the diaphyseal diameter, substantially larger than the window size typically used in clinical practice. The main concern with bypassing the cortical window by 2 cortical diameters is the violation of virgin bone that would otherwise be available for possible future re-revision surgery. Zweymuller et al. (2005) reported on the use of anterior cortical windows during revision hip arthroplasty in 41 cases, where the window was not bypassed by two cortical diameters in 40 of the patients. No periprosthetic fractures were reported at an average follow-up of 7 years. These results, in addition to the present senior author''s clinical experience, raised the question of the need to bypass cortical windows to prevent periprosthetic fractures. We designed a mechanical pig cadaveric study to determine and compare the risk of periprosthetic fracture for bypassed and non-bypassed anterior cortical windows.     

In situ fixation of slipped capital femoral epiphysis with Steinmann pins

Background and purpose

Slipped capital femoral epiphysis (SCFE) is often treated by surgical fixation; however, no agreement exists regarding technique. We analyzed the outcome of in situ fixation with Steinmann pins.

Patients and methods

All 67 subjects operated for slipped capital femoral epiphysis at Haukeland University Hospital during the period 1990–2007 were included. All were treated by in situ fixation with 2 or 3 parallel Steinmann pins (8 mm threads at the medial end). The follow-up evaluation consisted of clinical examination and hip radiographs. Radiographic outcome was based on measurements of slip progression, growth of the femoral neck, leg length discrepancy, and signs of avascular necrosis and chondrolysis.

Results

67 subjects (41 males) were operated due to unilateral slips (n = 47) or bilateral slips (n = 20). Mean age at time of diagnosis was 13 (7.2–16) years. Mean age at follow-up was 19 (14–30) years, with a mean postoperative interval of 6.0 (2–16) years. The operated femoral neck was 9% longer at skeletal maturity than at surgery, indicating continued growth of the femoral neck. At skeletal maturity, 12 subjects had radiographic features suggestive of a previous asymptomatic slip of the contralateral hip. The total number of bilateral cases of SCFE was 32, i.e half of the children had bilateral SCFE. 3 subjects required additional surgery and mild avascular necrosis of the femoral head was seen in 1 patient. None had slip progression or chondrolysis.

Interpretation

In situ pinning of SCFE with partly threaded Steinmann pins appears to be a feasible and safe method, with few complications. The technique allows further growth of the femoral neck.Slipped capital femoral epiphysis (SCFE) is a disease of unknown etiology, but mechanical, biological and hereditary factors are likely to play a role (Barrios et al. 2005, Murray and Wilson 2008). The rationale for treatment of SCFE is to restore hip function, prevent further slip, and to reduce the risk of subsequent degenerative changes. Several surgical techniques have been recommended such as cannulated screws (Chen et al. 2009), hook-pins (Hansson 1982), specially constructed screws (Wensaas and Svenningsen 2005), and most recently surgical hip dislocation with subcapital correction osteotomy (Leunig et al. 2007). However, currently there is no evidence to support the superiority of one particular technique over another.In situ fixation is advocated by most authors (Boyer et al. 1981, Carey et al. 1987, Givon and Bowen 1999) since peroperative reduction may increase the risk of avascular necrosis (Ordeberg et al. 1983, Carney et al. 1991, Lim et al. 2007). Physiodesis to prevent further growth—thus stabilizing the physis—is recommended by some authors (Carey et al. 1987, Aronsson and Karol 1996). Slip of the contralateral hip is reported in more than half of the cases (Hägglund et al. 1988, Castro et al. 2000) and controversies exist regarding prophylactic fixation of the contralateral hip. According to Jerre et al. (1994), more than two-thirds of the contralateral slips are asymptomatic and are therefore only detected at close follow-ups including hip radiographs at short intervals. Immediate prophylactic fixation of the contralateral hip has been advocated by several authors (Hägglund et al. 1988, Schultz et al. 2002, Krauspe et al. 2004).In this paper, we present clinical and radiographic results of a novel, simple technique for in situ fixation of the femoral head with partially threaded Steinmann pins to enable further growth of the femoral neck.