Molnupiravir for intra-household prevention of COVID-19: The MOVe-AHEAD randomized, placebo-controlled trial.

OBJECTIVES: To evaluate the efficacy and safety of molnupiravir for intra-household post-exposure prophylaxis (PEP) of COVID-19. METHODS: MOVe-AHEAD was a randomized, controlled, double-blind, phase 3 trial comparing molnupiravir (800 mg twice daily for 5 days) with placebo. Eligible participants were adult, unvaccinated, asymptomatic household contacts of patients with laboratory-confirmed COVID-19. The primary efficacy endpoint was the incidence of COVID-19 through day 14 in modified intention-to-treat (MITT) participants (those who received ≥1 dose of study intervention) without detectable SARS-CoV-2 at baseline, termed the MITT-VN population. Superiority of molnupiravir was prespecified as a stratified one-sided p-value of <0.0249 for the treatment difference in this endpoint. RESULTS: The MITT population comprised 763 participants randomized to molnupiravir and 764 to placebo; 83.6% had anti-SARS-CoV-2 antibodies at baseline. In the MITT-VN population, COVID-19 rates through day 14 were 6.5% with molnupiravir and 8.5% with placebo (one-sided p-value: 0.0848). In the molnupiravir arm, 25/35 of confirmed COVID-19 events (71.4%) occurred after completion of treatment (versus 17/49 [34.7%] for placebo). Adverse event rates were low and similar between molnupiravir and placebo. CONCLUSIONS: Molnupiravir was well-tolerated but did not meet the prespecified superiority criterion, possibly influenced in part by the high pre-existing immunity in the trial population.

Partnership in Ethiopia: University of Utah's and UCLA's Departments of Orthopaedics Collaboration With Soddo Christian Hospital in Ethiopia.

Collaborations between orthopaedic training programs in developed countries and international sites in austere environments offer abundant benefits and mutual enrichment. It is often assumed that the exchange is one-sided and we hope to dispel that assumption. Despite the logistical challenges inherent in these partnerships, our experience has been unanimously reviewed as "greatly beneficial" to visiting residents/faculty and surgeons/trainees at the host location. We hope that this article will (1) encourage faculty at training programs to permit and enable residents to experience international orthopaedics while still in training; (2) encourage faculty to visit international hospitals while contributing expertise in subspecialty surgery, research, and teaching; and (3) encourage international hospitals to create opportunities for clinical and research collaboration with academic orthopaedics departments.

Surgical Treatment of Chronic Elbow Dislocation Allowing for Early Range of Motion: Operative Technique and Clinical Results.

OBJECTIVES: To describe the surgical treatment and patient outcomes of chronic elbow dislocations. DESIGN: Retrospective review. SETTING: Two tertiary referral centers. PATIENTS/PARTICIPANTS: All patients with surgically treated chronic elbow dislocation with no associated articular fracture from January 2009 to January 2015. INTERVENTION: Review of patient demographics, injury chronicity, surgical technique, and patient outcomes. MAIN OUTCOME MEASUREMENT: Clinical outcomes included elbow range of motion and complications. Radiographic outcomes included the presence of heterotopic ossification. Patient-reported outcomes included the Mayo Elbow Performance Index (MEPI) and the Summary Outcome Determination (SOD). RESULTS: Thirty-two patients with mean follow-up of 22 months (range, 13-41 months) were included. The mean dislocation duration was 6 months (range, 1-34 months). The mean preoperative range of motion was 8 degrees (range, 0-30 degrees). There were no infections or recurrent dislocations. One patient developed transient ulnar nerve palsy postoperatively. There were no cases of new or progressive heterotopic ossification. The mean postoperative extension was 31 degrees (range, 0-75 degrees), and the mean postoperative flexion was 132 degrees (range, 95-150 degrees); the mean final arc of motion was 101 degrees (range, 50-140 degrees). The mean postoperative MEPI was 93 (range, 70-100), and the mean SOD score was 9 (range, 6-10). Using the MEPI, 97% (31/32 patients) had good or excellent outcome. There was no difference in flexion/extension arc or MEPI scores between groups of elbows older and younger than 17 years or dislocations less or more than 3 months. CONCLUSION: This is the largest case series of surgically treated patients with chronic elbow dislocation. Using our surgical technique, 97% of patients had good or excellent outcome with a low complication rate. Open reduction of chronic elbow dislocation can be accomplished while permitting early motion with minimal recurrent dislocation risk. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

State of Pelvic and Acetabular Surgery in the Developing World: A Global Survey of Orthopaedic Surgeons at Surgical Implant Generation Network (SIGN) Hospitals.

OBJECTIVES: To document the current state of pelvic and acetabular surgery in the developing world and to identify critical areas for improvement in the treatment of these complex injuries. DESIGN: A 50-question online survey. SETTING: International, multicenter. PATIENTS/PARTICIPANTS: One hundred eighty-one orthopaedic surgeons at Surgical Implant Generation Network (SIGN) hospitals, which represent a cross-section of institutions in low- and middle-income countries that treat high-energy musculoskeletal trauma. INTERVENTIONS: Administration and analysis of 50-question survey. MAIN OUTCOME MEASURES: Surgeon training and experience; hospital resources; volume and patterns of pelvic/acetabular fracture management; postoperative protocols and resources for rehabilitation; financial responsibilities for patients with pelvic/acetabular fractures. RESULTS: Complete surveys were returned by 75 institutions, representing 61.8% of the global SIGN nail volume. Although 96% of respondents were trained in orthopaedic surgery, 53.3% have no formal training in pelvic or acetabular surgery. Emergency access to the operating room is available at all responding sites, but computed tomography scanners are available at only 60% of sites, and a mere 21% of sites have access to angiography for pelvic embolization. Cannulated screws (53.3%) and pelvic reconstruction plates (56%) are available at just over half of the sites, and 68% of sites do not have pelvic reduction clamps and retractors. 21.3% of sites do not have access to intraoperative fluoroscopy. Responding hospitals see an average of 38.8 pelvic ring injuries annually, with 24% of sites treating them all nonoperatively. Sites treated an average of 22.5 acetabular fractures annually, with 34.7% of institutions treating them all nonoperatively. Patients travel up to 1000 km or 20 hours for pelvic/acetabular treatment at some sites. Although 78.7% of sites have inpatient physical or occupational therapy services, only 17% report access to home physical therapy, and only 9% report availability of nursing or rehabilitation facilities postdischarge. At over 80% of hospitals, patients and their families are at least partially responsible for payment of surgical, implant, hospital, and outpatient fees. Government aid is available for inpatient fees at over 40% of sites, but outpatient services are subsidized at only 28% of sites. CONCLUSIONS: We report the current state of pelvic and acetabular surgery in low- and middle-income countries. Our results identify significant needs in surgeon training, hospital resources, availability of instruments and implants, and access to appropriate postoperative rehabilitation services for pelvic and acetabular surgery in the developing world. Targeted programs designed to overcome these barriers are required to advance the care of pelvic and acetabular fractures in the developing world.

The SIGN nail for knee fusion: technique and clinical results.

PURPOSE: Evaluate the efficacy of using the SIGN nail for instrumented knee fusion. METHODS: Six consecutive patients (seven knees, three males) with an average age of 30.5 years (range, 18-50 years) underwent a knee arthrodesis with SIGN nail (mean follow-up 10.7 months; range, 8-14 months). Diagnoses included tuberculosis (two knees), congenital knee dislocation in two knees (one patient), bacterial septic arthritis (one knee), malunited spontaneous fusion (one knee), and severe gout with 90° flexion contracture (one knee). The nail was inserted through an anteromedial entry point on the femur and full weightbearing was permitted immediately. RESULTS: All knees had clinical and radiographic evidence of fusion at final follow-up and none required further surgery. Four of six patients ambulated without assistive device, and all patients reported improved overall physical function. There were no post-operative complications. CONCLUSION: The technique described utilizing the SIGN nail is both safe and effective for knee arthrodesis and useful for austere environments with limited fluoroscopy and implant options.

Management of Distal Tibial Metaphyseal Fractures With the SIGN Intramedullary Nail in 3 Developing Countries.

OBJECTIVES: To evaluate the effectiveness of the Surgical Implant Generation Network (SIGN) intramedullary (IM) nail in distal tibial metaphyseal fractures. DESIGN: Retrospective Case Series. SETTING: Three Level I trauma centers in 3 different developing countries from 2009 to 2013. PATIENT/PARTICIPANTS: One hundred sixty patients with 162 distal tibial metaphyseal fractures (AO/OTA 43-A). INTERVENTION: SIGN IM nailing was performed using hand reaming and without the use of an image intensifier. MAIN OUTCOME MEASUREMENTS: The primary outcome measures were the rate of union and complications. The secondary outcome measures were the effect of open fractures on outcomes, effectiveness and safety of open reduction of closed fractures, and risk factors for the development of malalignment and possible solutions. RESULTS: The average age of patients was 35.3 years. Seventy-nine percent were male. Sixty percent of the fractures were closed. The mean time to surgery was 4.1 days. Fracture union occurred in 97.3% of fractures with an average time to union of 105 days. Open reduction of closed fractures was performed in 51 fractures. Nonunion occurred in 3 patients (1.8%). Acceptable alignment (<5 degrees deformity) was found in 134 fractures (83%). Infection occurred in 14 patients (8.6%). Revision surgery was required in 10 fractures (6.2%). CONCLUSIONS: In developing settings, distal metaphyseal tibial fractures can be managed successfully with the SIGN IM nail. There is an increased risk for complications (P = 0.001) and infection (P = 0.0004) in open fractures. Open reduction of closed distal tibia fractures is safe and effective. Malalignment can be improved with fibula stabilization but indications remain unclear. For surgeons interested in international mission work, the SIGN IM nail is an effective tool in managing distal tibial fractures. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.