The role of a cryocompression device following total knee arthroplasty to assist in recovery: a randomised controlled trial.

PURPOSE: The study sought to investigate the effectiveness of a cryocompression Game Ready™ (GR) versus usual care protocol (UC) on early post-operative recovery following total knee arthroplasty. METHODS: This study prospectively randomised 72 total knee arthroplasties to a 2-week (from day 0) intervention of GR treatment (n = 36, 63.9% females) or UC of ice with static compression (n = 36, 45.7% females). Knee flexion and extension range of motion (ROM), a visual analogue pain scale and limb circumference were documented at day 1, 2 and 14, as well as 6 weeks post-surgery. Medication usage and length of hospital stay were documented. Patient-reported outcome measures (PROMs) included the Knee Injury and Osteoarthritis Outcome Score and a Patient Satisfaction Questionnaire. Statistical analysis using linear mixed modelling and analysis of variance table with Satterthwaite's method were used along with two-tailed t-tests. RESULTS: There were no significant group-by-time interactions regarding any of the outcomes. The GR group had 19% lost to follow-up at 2 weeks, while the UC group had 8%. The GR group demonstrated significantly better knee extension ROM at day 1 (p = 0.048) and day 14 (p = 0.007) compared with the UC group. There were no group differences (n.s.) observed in pain, flexion ROM, limb circumference, opioid use or PROMs. Overall, higher pain levels resulted in increased opioid intake (p = 0.002), older patients used significantly less opioids (p < 0.001) and males reported significantly less pain than females (p = 0.048). No adverse effects were observed due to either protocol. CONCLUSION: Despite patients gaining significantly more knee extension during the initial two-week intervention period when using GR compared to UC, this effect was likely due to chance. No further significant differences were observed between the groups during or after cession of the intervention. LEVEL OF EVIDENCE: Level 2.

Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial.

Importance: There remains a lack of randomized trials investigating aspirin monotherapy for symptomatic venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA). Objective: To determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE after THA or TKA. Design, Setting, and Participants: Cluster-randomized, crossover, registry-nested trial across 31 hospitals in Australia. Clusters were hospitals performing greater than 250 THA or TKA procedures annually. Patients (aged ≥18 years) undergoing hip or knee arthroplasty procedures were enrolled at each hospital. Patients receiving preoperative anticoagulation or who had a medical contraindication to either study drug were excluded. A total of 9711 eligible patients were enrolled (5675 in the aspirin group and 4036 in the enoxaparin group) between April 20, 2019, and December 18, 2020. Final follow-up occurred on August 14, 2021. Interventions: Hospitals were randomized to administer aspirin (100 mg/d) or enoxaparin (40 mg/d) for 35 days after THA and for 14 days after TKA. Crossover occurred after the patient enrollment target had been met for the first group. All 31 hospitals were initially randomized and 16 crossed over prior to trial cessation. Main Outcomes and Measures: The primary outcome was symptomatic VTE within 90 days, including pulmonary embolism and deep venous thrombosis (DVT) (above or below the knee). The noninferiority margin was 1%. Six secondary outcomes are reported, including death and major bleeding within 90 days. Analyses were performed by randomization group. Results: Enrollment was stopped after an interim analysis determined the stopping rule was met, with 9711 patients (median age, 68 years; 56.8% female) of the prespecified 15 562 enrolled (62%). Of these, 9203 (95%) completed the trial. Within 90 days of surgery, symptomatic VTE occurred in 256 patients, including pulmonary embolism (79 cases), above-knee DVT (18 cases), and below-knee DVT (174 cases). The symptomatic VTE rate in the aspirin group was 3.45% and in the enoxaparin group was 1.82% (estimated difference, 1.97%; 95% CI, 0.54%-3.41%). This failed to meet the criterion for noninferiority for aspirin and was significantly superior for enoxaparin (P = .007). Of 6 secondary outcomes, none were significantly better in the enoxaparin group compared with the aspirin group. Conclusions and Relevance: Among patients undergoing hip or knee arthroplasty for osteoarthritis, aspirin compared with enoxaparin resulted in a significantly higher rate of symptomatic VTE within 90 days, defined as below- or above-knee DVT or pulmonary embolism. These findings may be informed by a cost-effectiveness analysis. Trial Registration: ANZCTR Identifier: ACTRN12618001879257.

Effect of Aspirin vs Enoxaparin on 90-Day Mortality in Patients Undergoing Hip or Knee Arthroplasty: A Secondary Analysis of the CRISTAL Cluster Randomized Trial.

Importance: Ischemic heart disease remains the leading cause of mortality following hip and knee arthroplasty. Due to its antiplatelet and cardioprotective properties, aspirin has been proposed as an agent that could reduce mortality when used as venous thromboembolism (VTE) prophylaxis following these procedures. Objective: To compare aspirin with enoxaparin in reducing 90-day mortality for patients undergoing hip or knee arthroplasty procedures. Design, Setting, and Participants: This study was a planned secondary analysis of the CRISTAL cluster randomized, crossover, registry-nested trial performed across 31 participating hospitals in Australia between April 20, 2019, and December 18, 2020. The aim of the CRISTAL trial was to determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE following hip or knee arthroplasty. The primary study restricted the analysis to patients undergoing total hip or knee arthroplasty for a diagnosis of osteoarthritis only. This study includes all adult patients (aged ≥18 years) undergoing any hip or knee arthroplasty procedure at participating sites during the course of the trial. Data were analyzed from June 1 to September 6, 2021. Interventions: Hospitals were randomized to administer all patients oral aspirin (100 mg daily) or subcutaneous enoxaparin (40 mg daily) for 35 days after hip arthroplasty and 14 days after knee arthroplasty procedures. Main Outcomes and Measures: The primary outcome was mortality within 90 days. The between-group difference in mortality was estimated using cluster summary methods. Results: A total of 23 458 patients from 31 hospitals were included, with 14 156 patients allocated to aspirin (median [IQR] age, 69 [62-77] years; 7984 [56.4%] female) and 9302 patients allocated to enoxaparin (median [IQR] age, 70 [62-77] years; 5277 [56.7%] female). The mortality rate within 90 days of surgery was 1.67% in the aspirin group and 1.53% in the enoxaparin group (estimated difference, 0.04%; 95% CI, -0.05%-0.42%). For the subgroup of 21 148 patients with a nonfracture diagnosis, the mortality rate was 0.49% in the aspirin group and 0.41% in the enoxaparin group (estimated difference, 0.05%; 95% CI, -0.67% to 0.76%). Conclusions and Relevance: In this secondary analysis of a cluster randomized trial comparing aspirin with enoxaparin following hip or knee arthroplasty, there was no significant between-group difference in mortality within 90 days when either drug was used for VTE prophylaxis. Trial Registration: http://anzctr.org.au Identifier: ACTRN12618001879257.

Medial Patellofemoral Ligament Reconstruction Combined With Distal Realignment for Recurrent Dislocations of the Patella: 5-Year Results of a Randomized Controlled Trial.

BACKGROUND: Tibial tubercle transfer (TTT) and medial patellofemoral ligament (MPFL) reconstruction have both shown, either in isolation or in combination, to provide improved patellofemoral joint (PFJ) stability. There are few studies that provide evidence that this remains true in the long term. PURPOSE: To compare the long-term results of patellar instability after TTT with and without MPFL reconstruction in 2 randomized groups. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 34 patients (36 knees) were randomized to 2 groups. The first group underwent lateral release (LR) and TTT for confirmed maltracking of the patella (control group). The second group underwent MPFL reconstruction in addition to TTT and LR (reconstruction group). Patients were followed up with validated questionnaires (Kujala score, Tegner activity score), a visual analog scale (VAS) assessing their insecurity, and a clinical assessment at a minimum of 5 years postoperatively. Participants also underwent quantitative computed tomography (CT) at 1 year for comparison. Two patients in the control group and 1 patient in the reconstruction group were lost to follow-up at 5 years. RESULTS: There were no significant differences in the Kujala ( P = .75), Tegner ( P = .36), or VAS ( P = .75) scores at any time period. One patient in the control group sustained a patellar redislocation at 3 years. Five patients in the control group and 2 in the reconstruction group had functional failures and required reoperations; however, this was not statistically significant ( P = .30). There were no significant differences between groups in the time to return to school or work ( P = .65) or sports ( P = .38) after surgery. Overall patient satisfaction was higher in the reconstruction group compared with the control group ( P = .04), and quantitative CT scans showed that the reconstruction group had a statistically significant improvement in the mean patellar tilt (6° vs -8°, respectively; P = .03) and mean congruence angle (13° vs -11°, respectively; P = .03) in the quadriceps-contracted state compared with the control group. CONCLUSION: Reconstruction of the MPFL in addition to TTT and LR resulted in improved alignment parameters (congruence angle, patellar tilt angle) as well as patient satisfaction. The Kujala and Tegner scores were no different between the 2 groups at any time period. There was insufficient evidence to conclude that the addition of MPFL reconstruction to TTT results in fewer redislocations or reoperations. This study concludes that MPFL reconstruction improves PFJ alignment and patient satisfaction; however, further studies with larger patient numbers are required to satisfy its significance with respect to redislocation rates and functional scores in the long term.

Comparison of two intraoperative assessment methods for injuries to the ankle syndesmosis. A cadaveric study.

BACKGROUND: Intraoperative stress testing is required for the detection of syndesmosis instability following an ankle fracture. The present study compared two stress tests for the detection of syndesmotic injury. METHODS: A true mortise radiograph of the ankle was made for fourteen cadaver joints. Specimens were randomized into two groups to simulate ligament and syndesmosis injury on the basis of the Danis-Weber classification system. In the first group, the anterior inferior tibiofibular ligament was divided first (Weber B(r)), followed sequentially by division of the interosseous membrane (Weber C) and the deltoid ligament. In the second group, the deltoid ligament was divided first, followed by the anterior inferior tibiofibular ligament. Radiographs were made at each stage with use of two methods of stressing the ankle mortise: (1) external rotation of the foot with an external moment of 7.5 Nm, and (2) application of a lateral force of 100 N. Tibiofibular overlap, tibiofibular clear space, and medial clear space were measured. RESULTS: Lateral stress produced a significantly greater increase in the tibiofibular clear space than did the external rotation test for Weber C injuries and Weber C plus deltoid ligament injuries. A greater increase in the tibiofibular clear space was noted during the lateral stress test when both the deltoid and the anterior inferior tibiofibular ligament had been sectioned (p < 0.05). The external rotation stress test produced a significant increase in the medial clear space in the presence of isolated anterior inferior tibiofibular ligament and deltoid ligament injuries (p < 0.05). CONCLUSIONS: For the detection of syndesmotic instability at the site of ankle fractures on stress radiographs, the lateral stress test appeared to be superior to the external rotation stress test in this cadaver model.