Objectives
We sought to determine the effect of reaming on 1-year SF-36 and SMFA scores from the Study to Prospectively Evaluate Reamed Intramedullary Nails in patients with Tibial Fractures (SPRINT).
Design
Prospective randomized controlled trial. 1,319 patients were randomized to reamed or unreamed nails. Fractures were categorized as open or closed.
Setting
29 academic and community health centers across the US, Canada, and the Netherlands
Patients/Participants
1,319 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 (PCS) (42.9 v 43.4, p = 0.54, 95% Confidence Interval for the difference [CI] −2.1 to 1.1) or the SMFA Dysfunction Index (DI) (18.0 v 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 PCS, SMFA DI, and SMFA Bothersome Index (p < 0.001). Time and fracture type were significantly associated with functional outcome.
Conclusions
Reaming does not affect functional outcomes following 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 one year after surgery.