Background Emerging evidence suggests aspirin may be an effective venous thromboembolism (VTE) prophylaxis for orthopaedic trauma patients, with fewer bleeding complications. We used a patient-centered weighted composite outcome to globally evaluate aspirin versus low-molecular-weight heparin (LMWH) for VTE prevention in fracture patients. Methods We conducted an open-label randomized clinical trial of adult patients admitted to an academic trauma center with an operative extremity fracture, or a pelvis or acetabular fracture. Patients were randomized to receive LMWH (enoxaparin 30-mg) twice daily (n = 164) or aspirin 81-mg twice daily (n = 165). The primary outcome was a composite endpoint of bleeding complications, deep surgical site infection, deep vein thrombosis, pulmonary embolism, and death within 90 days of injury. A Global Rank test and weighted time to event analysis were used to determine the probability of treatment superiority for LMWH, given a 9% patient preference margin for oral administration over skin injections. Results Overall, 18 different combinations of outcomes were experienced by patients in the study. Ninety-nine patients in the aspirin group (59.9%) and 98 patients in the LMWH group (59.4%) were event-free within 90 days of injury. Using a Global Rank test, the LMWH had a 50.4% (95% CI, 47.7–53.2%, p = 0.73) probability of treatment superiority over aspirin. In the time to event analysis, LMWH had a 60.5% probability of treatment superiority over aspirin with considerable uncertainty (95% CI, 24.3–88.0%, p = 0.59). Conclusion The findings of the Global Rank test suggest no evidence of superiority between LMWH or aspirin for VTE prevention in fracture patients. LMWH demonstrated a 60.5% VTE prevention benefit in the weighted time to event analysis. However, this difference did not reach statistical significance and was similar to the elicited patient preferences for aspirin.
ObjectiveLimited evidence for the optimal venous thromboembolism (VTE) prophylaxis regimen in orthopaedic trauma leads to variability in regimens. We sought to delineate patient preferences towards cost, complication profile, and administration route (oral tablet vs. subcutaneous injection).DesignDiscrete choice experiment (DCE).SettingLevel 1 trauma center in Baltimore, USA.Participants232 adult trauma patients (mean age 47.9 years) with pelvic or acetabular fractures or operative extremity fractures.Primary and secondary outcome measuresRelative preferences and trade-off estimates for a 1% reduction in complications were estimated using multinomial logit modelling. Interaction terms were added to the model to assess heterogeneity in preferences.ResultsPatients preferred oral tablets over subcutaneous injections (marginal utility, 0.16; 95% CI: 0.11 - 0.21, P<0.0001). Preferences changed in favor of subcutaneous injections with an absolute risk reduction of 6.98% in bleeding, 4.53% in wound complications requiring reoperation, 1.27% in VTE, and 0.07% in death from pulmonary embolism (PE). Patient characteristics (sex, race, type of injury, time since injury) affected patient preferences (P<0.01).ConclusionsPatients preferred oral prophylaxis and were most concerned about risk of death from PE. Furthermore, the findings estimated the trade-offs acceptable to patients and heterogeneity in preferences for VTE prophylaxis.
Nearly half of adult fracture patients are vitamin D deficient (serum 25‐hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Many surgeons advocate prescribing vitamin D supplements to improve fracture healing outcomes; however, data supporting the effectiveness of vitamin D 3 supplements to improve acute fracture healing are lacking. We tested the effectiveness of vitamin D 3 supplementation for improving tibia and femur fracture healing. We conducted a single‐center, double ‐ blinded phase II screening randomized controlled trial with a 12‐month follow‐up. Patients aged 18–50 years receiving an intramedullary nail for a tibia or femoral shaft fracture were randomized 1:1:1:1 to receive (i) 150,000 IU loading dose vitamin D 3 at injury and 6 weeks ( n = 27); (ii) 4000 IU vitamin D 3 daily ( n = 24); (iii) 600 IU vitamin D 3 daily ( n = 24); or (iv) placebo ( n = 27). Primary outcomes were clinical fracture healing (Function IndeX for Trauma [FIX‐IT]) and radiographic fracture healing (Radiographic Union Score for Tibial fractures [RUST]) at 3 months. One hundred two patients with a mean age of 29 years (standard deviation 8) were randomized. The majority were male (69%), and 56% were vitamin D 3 deficient at baseline . Ninety‐nine patients completed the 3‐month follow‐up. In our prespecified comparisons, no clinically important or statistically significant differences were detected in RUST or FIX‐IT scores between groups when measured at 3 months and over 12 months. However, in a post hoc comparison, high doses of vitamin D 3 were associated with improved clinical fracture healing relative to placebo at 3 months (mean difference [MD] 0.90, 80% confidence interval [CI], 0.08 to 1.79; p = 0.16) and within 12 months (MD 0.89, 80% CI, 0.05 to 1.74; p = 0.18). The study was designed to identify potential evidence to support the effectiveness of vitamin D 3 supplementation in improving acute fracture healing. Vitamin D 3 supplementation, particularly high doses, might modestly improve acute tibia or femoral shaft fracture healing in healthy adults, but confirmatory studies are required. The Vita‐Shock trial was awarded the Orthopaedic Trauma Association's (OTA) Bovill Award in 2020. This award is presented annually to the authors of the most outstanding OTA Annual Meeting scientific paper. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.
To assess whether far‐cortical locking (FCL) screws alter the fracture site strain environment and allow shorter bridge plate constructs for supracondylar femoral fractures, we tested the fracture site displacement under force of synthetic left femora with a 5‐cm metaphyseal fracture gap, modeling comminution. Five models of nine constructs were tested (three types of diaphyseal screws [nonlocking, locking, and FCL] and two plate lengths [13 holes and 5 holes]). Long plate models using three or four diaphyseal screws (working length 13.5 or 7.5 cm, respectively) were compared with short plates with three diaphyseal screws (working length 7.5 cm). Models were loaded axially and torsionally; 100 cycles in random order. Primary outcome measures were axial and torsional fracture site stiffness. FCL screws decreased rotational stiffness 19% (P < .01) compared with baseline nonlocking screws in the same plate and working length construct, mirroring the effect (20% decrease in stiffness, P < .01) of nearly doubling the nonlocking construct working length (7.5‐13.5 cm). Similarly, FCL screws decreased axial stiffness 23% (P < .01) in the same baseline comparison. Fracture site displacement under loading comparable to a long working length nonlocked plate construct was achieved using a shorter FCL plate construct. By closely replicating the biomechanical properties of a long plate construct, a fracture site strain environment considered favorable in promoting fracture healing might still be achievable using a shorter plate length. Clinical Significance: It might be possible to optimize fracture site strain environment and displacement under loading using shorter FCL plate constructs. Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 00:00–00, 2020.
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