Carol A Lin1, Marc Swiontkowski, Mohit Bhandari, Stephen D Walter, Emil H Schemitsch, David Sanders, Paul Tornetta. 1. *Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Orthopedic Center, Los Angeles, CA; †Department of Orthopedic Surgery, Minneapolis, University of Minnesota, MN; ‡SPRINT Methods Center, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; §Department of Clinical Epidemiology and Biostatistics, Health Sciences Centre, Hamilton, ON, Canada; ‖Department of Orthopaedic Surgery, University of Toronto St. Michael's Hospital, Toronto, ON, Canada; ¶Department of Orthopedic Surgery, University of Western Ontario London Health Sciences Centre, London, ON, Canada; and **Department of Orthopedic Surgery, Boston Medical Center, Boston, MA.
Abstract
OBJECTIVES: We sought to determine the effect of reaming on 1-year 36-item short-form general health survey (SF-36) and short musculoskeletal function assessment (SMFA) scores from the Study to Prospectively Evaluate Reamed Intramedullary Nails in patients with Tibial Fractures. DESIGN: Prospective randomized controlled trial.1319 patients were randomized to reamed or unreamed nails. Fractures were categorized as open or closed. SETTING:Twenty-nine academic and community health centers across the US, Canada, and the Netherlands. PATIENTS/PARTICIPANTS: One thousand three hundred and nineteen skeletally mature patients with closed and open diaphyseal tibia fractures. INTERVENTION: Reamed versus unreamed tibial nails. MAIN OUTCOME MEASUREMENTS: SF-36 and the SMFA. Outcomes were obtained during the initial hospitalization to reflect preinjury status, and again at the 2-week, 3-month, 6-month, and 1-year follow-up. Repeated measures analyses were performed with P < 0.05 considered significant. RESULTS: There were no differences between the reamed and unreamed groups at 12 months for either the SF-36 physical component score [42.9 vs. 43.4, P = 0.54, 95% Confidence Interval for the difference (CI) -2.1 to 1.1] or the SMFA dysfunction index (18.0 vs. 17.6, P = 0.79. 95% CI, -2.2 to 2.9). At one year, functional outcomes were significantly below baseline for the SF-36 physical componentf score, SMFA dysfunction index, and SMFA bothersome index (P < 0.001). Time and fracture type were significantly associated with functional outcome. CONCLUSIONS:Reaming does not affect functional outcomes after intramedullary nailing for tibial shaft fractures. Patients with open fractures have worse functional outcomes than those with a closed injury. Patients do not reach their baseline function by 1 year after surgery. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
OBJECTIVES: We sought to determine the effect of reaming on 1-year 36-item short-form general health survey (SF-36) and short musculoskeletal function assessment (SMFA) scores from the Study to Prospectively Evaluate Reamed Intramedullary Nails in patients with Tibial Fractures. DESIGN: Prospective randomized controlled trial.1319 patients were randomized to reamed or unreamed nails. Fractures were categorized as open or closed. SETTING: Twenty-nine academic and community health centers across the US, Canada, and the Netherlands. PATIENTS/PARTICIPANTS: One thousand three hundred and nineteen skeletally mature patients with closed and open diaphyseal tibia fractures. INTERVENTION: Reamed versus unreamed tibial nails. MAIN OUTCOME MEASUREMENTS: SF-36 and the SMFA. Outcomes were obtained during the initial hospitalization to reflect preinjury status, and again at the 2-week, 3-month, 6-month, and 1-year follow-up. Repeated measures analyses were performed with P < 0.05 considered significant. RESULTS: There were no differences between the reamed and unreamed groups at 12 months for either the SF-36 physical component score [42.9 vs. 43.4, P = 0.54, 95% Confidence Interval for the difference (CI) -2.1 to 1.1] or the SMFA dysfunction index (18.0 vs. 17.6, P = 0.79. 95% CI, -2.2 to 2.9). At one year, functional outcomes were significantly below baseline for the SF-36 physical componentf score, SMFA dysfunction index, and SMFA bothersome index (P < 0.001). Time and fracture type were significantly associated with functional outcome. CONCLUSIONS: Reaming does not affect functional outcomes after intramedullary nailing for tibial shaft fractures. Patients with open fractures have worse functional outcomes than those with a closed injury. Patients do not reach their baseline function by 1 year after surgery. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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