RESUMO
PURPOSE: The purpose of this study was to develop a quality appraisal tool for the assessment of cadaveric biomechanical laboratory and other basic science biomechanical studies. METHODS: For item identification and development, a systematic review of the literature was performed. The content validity index (CVI) was used either to include or exclude items. The content validity ratio (CVR) was used to determine content validity. Weighting was performed by each panel member; the final weight was either up- or downgraded to the closest of 5% or 10%. Face validity was scored on a Likert scale ranked from 1 to 7. Test-retest reliability was determined using the Fleiss kappa coefficient. Internal consistency was assessed with Cronbach's alpha. Concurrent criterion validity was assessed against the Quality Appraisal for Cadaveric Studies scale. RESULTS: The final Biomechanics Objective Basic science Quality Assessment Tool (BOBQAT) score included 15 items and was shown to be valid, reliable, and consistent. Five items had a CVI of 1.0; 10 items had a CVI of 0.875. For weighting, 5 items received a weight of 10%, and 10 items a weight of 5%. CVR was 1.0 for 6 items and 0.75 for 9 items. For face validity, all items achieved a score above 5. For test-retest reliability, almost-perfect test-retest reliability was observed for 10 items, substantial agreement for 4 items, and moderate agreement for 1 item. For internal consistency, Cronbach's alpha was calculated to be 0.71. For concurrent criterion validity, Pearson's product-moment correlation was 0.56 (95% confidence interval [CI] = 0.38-0.70, P = .0001). CONCLUSION: Cadaveric biomechanical and laboratory research can be quantitatively scored for quality based on the inclusion of a clear and answerable purpose, demographics, specimen condition, appropriate bone density, reproducible technique, appropriate outcome measures, appropriate loading conditions, appropriate load magnitude, cyclic loading, sample size calculation, proper statistical analysis, results consistent with methods, limitations considered, conclusions based on results, and disclosure of funding and potential conflicts. CLINICAL RELEVANCE: Study quality assessments are important to evaluate internal and external validity and reliability and to identify methodological flaws and misleading conclusions. The BOBQAT score will help not only in the critical appraisal of cadaveric biomechanical studies but also in guiding the designs of such research endeavors.
RESUMO
PURPOSE: The purpose of this study was to evaluate the clinical and functional outcomes of failed plate fixation in distal tibia fractures salvaged with hexapod circular fixators. MATERIALS AND METHODS: The database of a specialized limb reconstruction center was searched for all patients with failed plate fixation undergoing limb reconstruction with a circular external fixator between 2008 and 2017. Patients between the ages of 18-65 years, with a symptomatic distal tibia malunion or non-union following plate and screw fixation were included. The SF-12 and Foot Function Index (FFI) scoring systems were used to measure clinical and functional outcomes. RESULTS: Ten patients with a mean age of 38 ± 13 years met the inclusion criteria. Seven patients had an infected non-union, two hypertrophic non-unions, and one a malunion. The mean follow-up was 41.7 ± 28.3 months. The mean duration of external fixation was 232.9 ± 146.6 days. The SF-12 demonstrated a mean score of 49.4 ± 7.7 for the physical component and a mean score of 55.3 ± 8.1 for the mental component. Five patients (50%) scored above 45 points for the SF12 physical component, and nine patients (90%) scored above 45 points for the mental component, indicating good outcome can be achieved. The mean FFI score was 24.9 ± 19.9, and six patients had a score below 14 points (good outcome). Radiological union was observed in all 10 patients at a mean of 29 ± 14 months. CONCLUSIONS: The results of this study suggest that hexapod circular external fixation is an attractive surgical alternative for the treatment of failed plate fixation of distal tibial fractures, and can reliably achieve bony union and result in very satisfactory clinical outcomes. LEVEL OF EVIDENCE: Level IV case series.