Effect of Tourniquet Use on Patient Outcomes After Cementless Total Knee Arthroplasty: A Randomized Controlled Trial

BackgroundTourniquet use is common in total knee arthroplasty (TKA), but debate exists regarding its use and effect on patient outcomes. The study purpose was to compare the effect of short tourniquet (ST) time vs long tourniquet (LT) time on pain, opioid consumption, and patient outcomes.MethodsPatients were prospectively randomized to an ST time of 10 min vs LT time. A total of 100 consecutive patients undergoing primary cementless robotic-assisted TKA underwent randomization, with 5 patients unable to complete follow-up, leaving 49 in the ST group and 46 in the LT cohort. Visual analog scale pain scores, morphine equivalent, serum creatine kinase, distance walked, range of motion, length of stay (LOS), surgical time, hemoglobin (Hgb), and Knee Society Scores (KSS) were prospectively collected.ResultsVisual analog scale pain was statistically equivalent at 24, 48, and 72 hours and at 2 and 6 weeks postoperatively. Morphine equivalent consumption was 36 vs 44 (P = .03), 48 vs 50 (P = .72), 31 vs 28 (P = .57), and 4.7 vs 5.5 (P = .75) in the LT vs ST cohorts at 24 hours, 48 hours, 2weeks, and 6weeks postoperatively. Change in Hgb postoperative day 1 was 2.7 in both groups (P = .975). Postoperative day 1 creatine kinase-MB was 3.7 and 3.0 (P = .30) in LT and ST cohorts. Six-week postoperative KSS Knee and Function scores were 82.4 and 70.5 in LT group vs 80.8 and 72.3 in ST group (P = .61 and P = .63). Postoperative range of motion, LOS, and surgical time were equivalent.ConclusionThis study demonstrates no significant advantage of ST use in primary TKA with respect to opioid consumption, patient-reported pain, KSS scores, LOS, or postoperative Hgb level.     

The Fragility of Tourniquet Use in Total Knee Arthroplasty: A Systematic Review of Randomized Controlled Trials

BackgroundPhysicians utilize P-values to interpret clinical trial data and guide patient-care decisions. Fragility analysis assesses the stability of statistical findings in relation to outcome event reversals. This study assessed the statistical fragility of recent randomized controlled trials (RCTs) investigating tourniquet use in total knee arthroplasty (TKA).MethodsWe queried PubMed, EMBASE, and MEDLINE for RCTs comparing outcomes in TKA based on tourniquet use. Fragility index (FI) and reverse fragility index (reverse FI) were calculated – for significant and nonsignificant outcomes, respectively – as the number of outcome reversals required to change statistical significance. The fragility quotient (FQ) was calculated by dividing the FI or reverse FI by the sample size. Median overall FI and FQ were calculated for all included outcomes, and sub-analyses were performed by reported significance. The literature search yielded 23 studies reporting 91 total dichotomous outcomes.ResultsOverall median FI was 4 with an interquartile range (IQR) of 3 to 6. Overall median FQ was 0.0476 (IQR 0.0291 to 0.0867). A total of 11 outcomes were statistically significant with a median FI and FQ of 2 (IQR 1.5 to 5) and 0.0200 (IQR 0.0148 to 0.0484), respectively. There were 80 outcomes that were nonsignificant with a median reverse FI of 4 (IQR 3 to 6). Loss to follow-up was greater than the median FI in 17.6% of outcomes.ConclusionAltering a small number of outcomes is often sufficient to reverse findings in RCTs evaluating tourniquet use in TKA. We recommend including fragility analyses to increase reliability in the interpretation of study conclusions.     

A Randomized Controlled Trial of Intraarticular Ropivacaine for Pain Management Immediately Following Total Knee Arthroplasty

Total knee arthroplasty (TKA) is a commonly performed procedure for the treatment of end-stage arthritis of the knee. Pain control following TKA is difficult to manage in some patients. We examined the use of a postoperative intraarticular injection of 100 mL of 0.2% (200 mg) ropivacaine in a double-blind, prospective, placebo-controlled pilot study to evaluate its use as a pain control modality. All patients received general anesthesia. Postoperatively, patients were placed on intravenous patient-controlled analgesia with morphine. The ropivacaine group showed an early trend in lower visual analog scale (VAS) scores when compared with the placebo group. Patients receiving ropivacaine used a similar amount of narcotics compared with the placebo group. Intraarticular ropivacaine used for pain control after TKA demonstrated no statistically significant difference in lowering VAS scores or narcotic usage; therefore, intraarticular ropivacaine as a single modality is not recommended for effective pain management.     

Randomized Controlled Trial of Radiographic and Patient-Assessed Outcomes Following Fixed Versus Rotating Platform Total Knee Arthroplasty

This prospectively blinded randomized controlled study evaluated the difference in the functional and radiological outcomes in patients who received a press-fit condylar Sigma cemented cruciate-substituting total knee arthroplasty with either a rotating platform (RP) or a fixed bearing (FB). There were 51 joints in 49 patients: 24 joints in the RP group (mean follow-up, 43 months) and 27 joints in the FB group (mean follow-up, 40 months). At baseline, there was no significant difference in age, body mass index, preoperative diagnosis, Charnley class, range of motion, clinical and functional scores, between the RP and FB groups. At mid-term follow up both the RP and FB give equivalent results, but patients with the RP tended to have a higher activity level score.     

A Prospective Randomized Controlled Trial Comparing Medial-Pivot versus Posterior-Stabilized Total Knee Arthroplasty

BackgroundThe medial-pivot (MP) design for total knee arthroplasty (TKA) aims to restore more natural “ball-and-socket” knee kinematics compared to the traditional posterior-stabilized (PS) implants for TKA. The objective of this study is to determine if there was any difference in functional outcomes between patients undergoing MP-TKA vs PS-TKA.MethodsThis prospective randomized controlled trial consisted of 43 patients undergoing MP-TKA vs 45 patients receiving a single-radius PS-TKA design. The primary outcome was postoperative range of motion (ROM). Secondary outcomes included the Western Ontario and McMaster Universities Arthritis Index, Oxford Knee Score, Knee Society Score (KSS), and radiological outcomes. All study patients were followed-up for 2 years after surgery.ResultsPatients undergoing MP-TKA had comparable ROM at 1 year (114.6° ± 16.3° vs 111.3° ± 17.8° respectively, P = .88) and 2 years after surgery (114.9° ± 15.5° vs 114.9° ± 16.4° respectively, P = .92) compared to PS-TKA. There were also no differences in Western Ontario and McMaster Universities Arthritis Index (26.8 ± 19.84 vs 22.0 ± 12.03 respectively, P = .14), Oxford Knee Score (42.7 ± 8.1 vs 42.3 ± 6.7 respectively, P = .18), KSS clinical scores (82.9 ± 16.96 vs 81.42 ± 10.45 respectively, P = .12) and KSS functional scores (76.2 ± 18.81 vs 73.93 ± 8.53 respectively, P = .62) at 2-year follow-up. There was no difference in postoperative limb alignment or complications.ConclusionThis study demonstrated excellent results in both the single-radius PS-TKA design and MP-TKA design. No differences were identified at 2-year follow-up with respect to postoperative ROM and patient-reported outcome measures.     

A Smartwatch Paired With A Mobile Application Provides Postoperative Self-Directed Rehabilitation Without Compromising Total Knee Arthroplasty Outcomes: A Randomized Controlled Trial

BackgroundSelf-directed rehabilitation (SDR) after total knee arthroplasty (TKA) has not been traditionally recommended. The purpose of this study was to determine if there was an impact on postoperative outcomes with the use of an SDR program after primary TKA.MethodsIn this prospective, randomized, multicenter, controlled trial, we paired a smartwatch with a mobile application, providing an SDR program after TKA. Three groups were examined in this level I study: (1) control group (formal physical therapy [PT]), (2) high exercise compliance group, and (3) low exercise compliance group. Patient-reported outcome measures (PROMs) of knee injury and osteoarthritis outcome scores, joint replacement (KOOS, JR), and EuroQol five-dimension five-level (EQ-5D-5L) along with range of motion (ROM) and manipulation rates were evaluated.ResultsThree hundred thirty-seven patients were enrolled in two groups with 184 in the control group and 153 in the study groups (90 in the high-compliance group and 63 in the low-compliance group). The KOOS, JR score was statistically lower in the low-compliance group in net change from preoperative scores at 3 months (P = .046) and 6 months (P = .032) than that in the control group; difference was noted at 6 months for the high-compliance group, P = .036. However, these did not meet the threshold of 8.02 units for KOOS JR minimal clinically important difference. No differences were seen in PROMs at other time intervals and in manipulation rates or ROM.ConclusionPostoperative outcomes including manipulation under anesthesia, ROM, and PROMs were not different when a smartwatch paired with a self-directed PT mobile application was compared with traditional formal PT. Surgeons can consider this an appropriate alternative to traditional PT programs after TKA.     

Evaluating the Effect of Intravenous Acetaminophen in Multimodal Analgesia After Total Hip Arthroplasty: A Randomized Controlled Trial

BackgroundPostoperative pain is a significant concern of patients before surgery. Multimodal pain management is an effective method of pain control after major orthopedic surgery. Acetaminophen is the most commonly used analgesic for the management of pain. It was hypothesized that 1000 mg of intravenous acetaminophen (IA) dosed every 6 hours would significantly reduce the postoperative pain score at rest and the opioid consumption volume in patients who would undergo total hip arthroplasty (THA) when compared to a control group.MethodsA single-center, prospective, open-label randomized control study was conducted. A total of 97 patients undergoing unilateral primary THA were divided into 2 groups: the study group (IA) (n = 45) and the control group (n = 52). The study group received administered IA after surgery, while the control group received only a standard pain control. Both groups received a preoperative femoral nerve block and postoperative intravenous fentanyl citrate. The primary outcome was the evaluation of the pain score at rest 24 hours after surgery. The pain score was measured using the Numerical Rating Scale. The primary outcome of this study was analyzed using generalized estimating equation.ResultsThe IA group had a significant improvement in Numerical Rating Scale score at rest 24 hours after THA compared to the control group (−0.91, 95% confidence interval −1.56 to −0.26, P = .006), suggesting a positive effect of IA usage for pain relief. The total fentanyl citrate consumption after surgery for 24 hours was significantly lower in the IA group than those of the control group (52.07 ± 7.64 vs 57.83 ± 12.44 mg, P < .001).ConclusionPostoperative administration of IA significantly reduced the postoperative pain score and opioid consumption volume after primary THA. IA was useful as one role of multimodal pain management after THA.Level of Evidence: Level 2.     

Randomized Controlled Trial of Sensor-Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty

BackgroundDespite advances in total knee arthroplasty (TKA) technology, up to 1 in 5 patients remain dissatisfied. This study sought to evaluate if sensor-guided knee balancing improves postoperative clinical outcomes and patient satisfaction compared to a conventional gap balancing technique.MethodsWe undertook a prospective double-blind randomized controlled trial of patients presenting for elective primary TKA to determine a difference in TKA soft tissue balance between a standard gap balancing (tensiometer) approach compared to augmenting the balance using a sensor-guided device. The sensor-guided experimental group had adjustments made to achieve a balanced knee to within 15 pounds of intercompartmental pressure difference. Secondary outcomes included differences in clinical outcome scores at 6 months and 1 year postoperative, including the Oxford Knee Score and Knee Society Score and patient satisfaction.ResultsThe sample comprised of 152 patients, 76 controls and 76 experimental sensor-guided cases. Within the control group, 36% (27/76) of knees were unbalanced based on an average coronal plane intercompartmental difference >15 pounds, compared to only 5.3% (4/76) within the experimental group (P < .0001). There were no significant differences in 1-year postoperative flexion, Knee Society Score, or Oxford scores. Overall, TKA patient satisfaction at 1 year was comparable, with 81% of controls and experimental cases reporting they were very satisfied (P = .992).ConclusionDespite the use of the sensor-guided knee balancer device to provide additional quantitative feedback in the evaluation of the soft tissue envelope during TKA, we were unable to demonstrate improved clinical outcomes or patient satisfaction compared to our conventional gap balancing technique.     

Effect of Different Tourniquet Pressure on Postoperative Pain and Complications After Total Knee Arthroplasty: A Prospective,Randomized Controlled Trial

BackgroundTourniquet pressure inflation is commonly selected between 100 and 150 mm Hg above the systolic blood pressure (SBP). Given the lack of evidence to support a given inflation pressure, our study aimed to ascertain the lowest tourniquet pressure that facilitated total knee arthroplasty (TKA) and resulted in the least postoperative pain and complications.MethodsIn a double-blind, randomized controlled trial of patients scheduled for unilateral primary TKA, 150 were assigned to use tourniquet pressures of SBP + 75 mm Hg (group I), SBP + 100 mm Hg (group II), and SBP + 150 mm Hg (group III). The quality of the bloodless field, total blood loss, and limb swelling were determined perioperatively. Clinical outcomes were evaluated by visual analog scale for pain at thigh and surgical site, serum creatinine phosphokinase levels, wound complications, range of motion, and Knee Society Score.ResultsVisual analog scale for pain at thigh and surgical site were lowest in group I (P < .01) and highest in group III (P < .01). However, the quality of bloodless field at the tibial cutting surface was significantly better in group III compared to group I/II but not at the femoral cutting surface. The total blood loss and limb swelling showed no difference among 3 groups. Postoperative serum creatinine phosphokinase levels at 24 and 48 hours and wound complications in group III were significantly higher than group I (P < .01) and group II (P < .01). Nevertheless, postoperative knee range of motion and Knee Society Score were not significantly different among 3 groups.ConclusionPost TKA, the lowest tourniquet pressure was associated with significantly less postoperative tourniquet and surgical site pain, muscle damage, and wound complications.     

Higher Tissue Concentrations of Vancomycin Achieved With Low-Dose Intraosseous Injection Versus Intravenous Despite Limited Tourniquet Duration in Primary Total Knee Arthroplasty: A Randomized Trial

BackgroundVancomycin use has been suggested in high risk patients undergoing total knee arthroplasty (TKA). Previous literature has shown that a lower dose (500 mg) of vancomycin given by intraosseous regional administration (IORA) achieves tissue concentrations 4-10 times higher than intravenous (IV) administration. There is increasing interest in performing TKA with limited tourniquet inflation time. The purpose of this study is to evaluate whether IORA of vancomycin can achieve effective tissue concentrations with limited tourniquet inflation time.MethodsBased on prior power calculations, 24 patients undergoing primary TKA were randomized into 2 groups. Group IV-Systemic received weight-based (15 mg/kg) vancomycin with the tourniquet inflated for cementation only. Group IORA received 500 mg vancomycin via IORA after tourniquet inflation which remained inflated for 10 minutes, then reinflated for cementation only. Vancomycin concentrations from tissue, serum, and drain fluid were compared between the 2 groups.ResultsMedian vancomycin concentrations in tissue were significantly higher (5-15 times) at all time points in the IORA group. Concentrations in fat at the time of wound closure, after the tourniquet had been deflated for most of the procedure, were 5.2 μg/g in Group IV-Systemic and 33.1 μg/g in Group IORA (P < .001). Median bone concentrations taken just prior to cementation were 7.9 μg/g in Group IV-Systemic and 21.8 μg/g in Group IORA (P = .006). There were no complications related to IORA.ConclusionFor surgeons who wish to limit tourniquet time and when indicated to use vancomycin, low-dose vancomycin IORA achieves tissue concentrations 5-15 times higher than those achieved by IV administration.Level of EvidenceLevel 1 therapeutic randomized trial.     

Effect on Hospital Length of Stay of Tourniquet Use During Internal Fixation of Ankle Fractures: Randomized Controlled Trial

Approximately 50% of ankle fractures require internal fixation. A tourniquet is often used to create a bloodless operative field, but its effect on hospital length of stay (LOS) is unclear. This article reports a parallel-group observer-blinded randomized trial of the effect of tourniquet use on LOS. One hundred eighty-eight adult patients requiring internal fixation of ankle fracture were randomized to surgery with or without a tourniquet. LOS was analyzed on intention-to-treat principles using Poisson regression. As a secondary outcome, duration of operation was analyzed by analysis of covariance. Mean LOS was 1.79 ± 1.50 days in the tourniquet group and 1.65 ± 1.11 days in the no-tourniquet group. The covariate-adjusted rate ratio for LOS (reference group: no tourniquet) was 1.084 (95% confidence interval 0.871, 1.348; p?=?.470). Sensitivity analyses (unadjusted intention-to-treat analysis and as-treated analysis) gave similar nonsignificant results. The covariate-adjusted mean difference in duration of operation was 3.03 minutes (95% confidence interval –4.96, 11.02; p?=?.455), favoring the tourniquet group; sensitivity analyses again gave similar results. Adverse events did not differ significantly between groups. In conclusion, the use of a tourniquet during internal fixation does not significantly influence hospital LOS, of which preinjury medical condition of the patient appears to be the most important determinant.     

Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective,Randomized, Controlled Trial

Background

Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA).

Total Knee Arthroplasty Using Bicruciate-Stabilized or Posterior-Stabilized Knee Implants Provided Comparable Outcomes at 2 Years: A Prospective,Multicenter, Randomized,Controlled, Clinical Trial of Patient Outcomes

Background

The bicruciate-stabilized (BCS) knee arthroplasty was developed to replicate normal knee kinematics. We examined the hypothesis that patients with osteoarthritis requiring total knee arthroplasty (TKA) will have better functional outcome and satisfaction with the BCS implant compared with an established posterior cruciate-stabilized implant.

Multiple Doses of Perioperative Dexamethasone Further Improve Clinical Outcomes After Total Knee Arthroplasty: A Prospective,Randomized, Controlled Study

Background

This study aimed to evaluate the effect and safety of multiple doses of preoperative dexamethasone on pain and recovery after total knee arthroplasty (TKA).

Optimized Tourniquet Use in Primary Total Knee Arthroplasty: A Comparative,Prospective, and Randomized Study

BackgroundThe results of recent studies investigating tourniquet (TNQ) use for knee arthroplasty are controversial. Therefore, this study aimed to compare patients undergoing total knee arthroplasty who did not have a TNQ to those in whom an optimized TNQ protocol was applied.MethodsWe prospectively evaluated 127 patients who had knee osteoarthritis who had undergone total knee arthroplasty and randomized them into two groups: “without TNQ” and “optimized TNQ” (TNQ inflation before skin incision, deflation after cementing, with pressure one hundred millimeters of mercury above the systolic blood pressure, and without articular suction drain usage). The means of surgery and TNQ duration, blood loss, number of blood transfusions, degree of pain, edema, range of motion (ROM), functional score over time, and postoperative complications were compared between the groups. Statistical significance was set at P < .05.ResultsNo significant differences were found in terms of surgical timing, blood loss, thigh and knee pain, edema, ROM, functional scores, and complications between the “without TNQ” and “optimized TNQ” groups.ConclusionThe use of an optimized TNQ in primary total knee arthroplasty presents similar clinical results to surgery without a TNQ and did not increase the incidence of postoperative complications. Its use allowed surgery to occur with the benefits of a clean and dry surgical field provided by TNQ without increasing procedure-related comorbidities.     

Intraoperative Ketamine in Total Knee Arthroplasty Does Not Decrease Pain and Narcotic Consumption: A Prospective Randomized Controlled Trial

BackgroundMultiple studies have demonstrated that ketamine, a glutamate receptor blocker, may decrease postoperative pain in abdominal and orthopedic surgeries. However, its role with spinal anesthesia and total knee arthroplasty (TKA) remains unknown. The purpose of this study is to determine the efficacy of subanesthetic dosing of ketamine during TKA on postoperative pain and narcotic consumption.MethodsIn this prospective, randomized, double-blinded clinical trial, we enrolled 91 patients undergoing primary TKA with spinal anesthesia in a single institution from 2017 to 2018. Patients were randomized to receive intraoperative ketamine infusion at a rate of 6 mcg/kg/min for 75 minutes or a saline placebo. All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Patient-reported visual analog pain scores were calculated preoperatively, postoperative days (POD) 0-7, and 2 weeks. Narcotic consumption was evaluated on POD 0 and 1.ResultsThere was no difference in average pain between ketamine and placebo at all time points except for at PODs 1 (45 vs 56, P = .041) and 4 (39 vs 49, P = .040). For least pain experienced, patients administered with ketamine experienced a reduction in pain only at POD 4 (22 vs 35, P = .011). There was no difference in maximum pain cohorts at all time points of the study or in-hospital morphine equivalents between the 2 cohorts.ConclusionAs part of multimodal pain management protocol, intraoperative ketamine does not result in a clinically significant improvement in pain and narcotic consumption following TKA.     

Cannabis Use Does Not Affect Outcomes After Total Knee Arthroplasty

BackgroundThe self-reported use of cannabis has increased since its recent legalization in several states. The primary purpose of this study is to report total knee arthroplasty (TKA) outcomes in patients using cannabis.MethodsSeventy-one patients who underwent a primary unilateral TKA with minimum 1-year follow-up, who self-reported cannabis use, were retrospectively reviewed. The study period was from January 2014 to February 2018 at a single institution. Patients with a history of opioid consumption, alcohol abuse, tobacco, or illicit drug use were excluded. A matched control was conducted based on age, body mass index, gender, smoking status, and insurance type (surrogate of socioeconomic status) in patients with a unilateral TKA who did not report cannabis use. Outcome measures included Knee Society Scores (KSS), range of motion, Veterans RAND-12 mental and physical component scores. No preoperative differences were noted with these measures. Postoperative complications were recorded and reported.ResultsNo difference in length of stay was noted between the users (46.9 hours ± 15.7) and nonusers (49.3 hours ± 20.4) (P = .464). In-hospital total morphine equivalents did not differ between the 2 groups (user = 137 ± 104 mg, nonuser = 146 ± 117 mg, P = .634). Postoperative range of motion did not differ between users (128.4° ± 10.4°) and nonusers (126.9° ± 7.5°) (P = .346). No mean differences in follow-up KSS (user = 180.1 ± 24.9, nonuser = 172.0 ± 33.9, P = .106) or total change (user = 61.7 ± 32.8, nonuser = 62.7 ± 30.7, P = .852) in KSS were noted. Likewise, no significant mean differences in Veterans RAND-12 (mental component scores: user = 54.8 ± 9.3, nonuser = 55.9 ± 8.79, P = .472; physical component scores: user = 48.3 ± 9.9, nonuser = 45.8 ± 10.1, P = .145) scores were demonstrated. There were no differences in readmissions (user = 5, nonuser = 4, P = .730) or reoperations (user = 5, nonuser = 2, P = .238).ConclusionCannabis use does not appear to influence (adverse or beneficial) short-term outcomes in patients undergoing a primary TKA. Further studies are warranted to determine the efficacy and safety of cannabis as a constituent of multimodal pain management following TKA before endorsements can be made by orthopedic surgeons.