PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients.

INTRODUCTION: Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients. METHODS AND ANALYSIS: PREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections. ETHICS AND DISSEMINATION: The PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients. TRIAL REGISTRATION NUMBER: NCT02984384.

Post-traumatic ulnar artery thrombosis: outcome of arterial reconstruction using reverse interpositional vein grafting at 2 years minimum follow-up.

PURPOSE: Treatment of posttraumatic symptomatic ulnar artery thrombosis (UAT) is controversial. This study reports the outcome at 2 years minimum follow-up of a uniform approach using reversed interpositional vein grafting to treat symptomatic patients with UAT. METHODS: The records of all patients with vascular disease of the upper extremity who were revascularized at the authors' institution were retrospectively reviewed, and the following inclusion criteria were applied: (1) arteriographically proven UAT treated with excision of the involved segment and reversed interpositional vein grafting; (2) absence of collagen vascular disease, coagulopathy, or peripheral vascular disease, (3) minimum follow-up of 24 months. Twelve patients (13 hands) were identified and evaluated before surgery and at final follow-up using the following health-related quality of life outcome instruments: (1) McCabe cold sensitivity severity scale, (2) McGill visual analog pain scale, (3) Levine symptom and function scale, and (4) Wake Forest University symptom scale (pain, numbness, and cold intolerance). Digital microvascular perfusion testing (laser Doppler perfusion imaging and isolated cold stress testing) was also performed, and the final test was compared with 28 normal controls. All patients were evaluated for graft patency as determined by Allen's testing and/or Doppler ultrasound. RESULTS: Ten of the 13 grafts were patent at final follow-up (77% patency rate). In all the patients with patent grafts, the Levine symptom scale, the McGill visual analog pain scale, the McCabe cold sensitivity severity scale, and the isolated cold stress testing responses of the patients were significantly improved at final follow-up. Isolated cold stress testing responses were not different from those of normal controls. The changes in the Levine function scale, Wake Forest University scale, and laser Doppler perfusion imaging were not significant. In the nonpatent grafts (3 of 13), 2 patients still complained of pain, numbness, and cold sensitivity, whereas 1 patient has minimal symptoms and continues to improve. CONCLUSIONS: Successful arterial reconstruction in symptomatic posttraumatic UAT decreases symptoms, improves function and microvascular physiology, and has a positive effect on the health-related quality of life. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Analysis of outcomes of anterior cruciate ligament repair with 5-year follow-up: allograft versus autograft.

PURPOSE: To prospectively compare outcomes of primary anterior cruciate ligament (ACL) reconstruction with either Achilles tendon allograft with soft-tissue fixation or standard bone-patellar tendon-bone autograft with interference screw fixation. TYPE OF STUDY: Prospective comparative case series. METHODS: A group of 41 patients who underwent soft-tissue allograft reconstruction and a group of 118 patients who underwent autograft bone-patellar tendon-bone reconstruction were included in the final results. Patients were evaluated preoperatively and postoperatively at 1 to 2 weeks, 6 weeks, 3 months, 6 months, and then annually for 5 years. Objective measures of outcome included KT-1000 measurements, range of motion, ligamentous integrity, thigh atrophy, and International Knee Documentation Committee score. Subjective evaluations included patient completion of 5 questionnaires documenting functional status, pain, and health-related quality of life: (1) the short-form McGill Pain Questionnaire, (2) a patient subjective assessment of knee function and symptoms, (3) a patient subjective assessment follow-up, (4) a knee pain scale, and (5) the RAND 36-Item Health Survey. Mixed models analysis of variance was used to compare the outcomes of the treatment groups using baseline values of the study variables as a covariate. RESULTS: Autograft patients reported significantly more pain on the bodily pain subscale of the RAND-36 than the allograft group at 1 week (P = .0006), 6 weeks (P = .0007), and 3 months (P = .0270). Autograft patients reported more pain than allograft patients on the McGill Pain Scale visual analog scale at 1 to 2 weeks (P < .0001) and 6 weeks (P = .0147). Patient assessment of function and symptoms showed that a higher proportion of patients reported normal or nearly normal knee function in the allograft group than in the autograft group at 3 months (33% v 14%, P = .0558, respectively). Fewer activity limitations were reported by allograft patients than autograft patients at 6 weeks (P = .0501), 3 months (P = .0431), and 6 months (P = .0014). After reconstruction, the allograft group displayed significantly more laxity in KT-1000 measurements at all time points than the autograft group (P = .0520). These measurements decreased over time for both groups (P < .0001). CONCLUSIONS: Five-year follow-up of patients undergoing ACL reconstruction with allograft versus autograft were compared objectively and subjectively. Both groups of patients achieved similar long-term outcomes. Overall, the allograft patients reported less pain at 1 and 6 weeks after surgery, better function at 1 week, 3 months, and 1 year, and fewer activity limitations throughout the follow-up period. LEVEL OF EVIDENCE: Level II, prospective cohort study.