Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design.

摘要: Background Surgeons agree on the benefits of operative treatment tibial fractures - most common long bone with an intramedullary rod or nail. Rates re-operation remain high between 23% and 60% in prior trials two alternative nailing approaches, reamed non-reamed, each have a compelling biological rationale strong proponents, resulting ongoing controversy regarding which is better. Methods/design The objective this trial was to assess impact versus non-reamed rates patients open closed shaft. study prospectively evaluate nails (S.P.R.I.N.T) multi-center, randomized including 29 clinical sites Canada, United States Netherlands enrolled 1200 skeletally mature (Gustilo Types I-IIIB) (Tscherne 0-3) shaft amenable surgical Patients received statically locked nail either insertion. first strategy involved fixation fracture following reaming enlarge canal (Reamed Group). second without (Non-Reamed Patients, outcome assessors, data analysts were blinded allocation. Peri-operative care standardized, re-operations before 6 months proscribed. followed at discharge, 2 weeks post-discharge, weeks, 3, 6, 9, 12 post surgery. A committee, allocation, adjudicated all outcomes. Discussion primary promote healing, treat infection, preserve limb (fasciotomy for compartment syndrome after nailing). composite comprising re-operations: grafts, implant exchanges, dynamizations, gaps less than 1 cm Infections fasciotomies considered events irrespective gap. We planned priori conduct subgroup analysis outcomes fractures. S.P.R.I.N.T largest collaborative evaluating orthopaedic interventions methodological rigor will set new benchmarks future field its results important patient care. registered [ID NCT00038129] research ethics approval (REB#99-077).