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Randomized Controlled Trial
. 2016 Mar;30(3):142-8.
doi: 10.1097/BOT.0000000000000497.

Reaming Does Not Affect Functional Outcomes After Open and Closed Tibial Shaft Fractures: The Results of a Randomized Controlled Trial

Carol A Lin  1 , Marc Swiontkowski, Mohit Bhandari, Stephen D Walter, Emil H Schemitsch, David Sanders, Paul Tornetta 3rd
Affiliations
Randomized Controlled Trial

Reaming Does Not Affect Functional Outcomes After Open and Closed Tibial Shaft Fractures: The Results of a Randomized Controlled Trial

Carol A Lin et al. J Orthop Trauma. 2016 Mar.

Erratum in

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.

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Conflict of interest statement

Conflicts of Interest: The authors have no relevant conflicts of interest

Figures

Figure 1
Figure 1
Flowchart for patient enrollment and randomization.
Figure 2
Figure 2
Reamed and unreamed SF-36 and SMFA scores over time stratified by open versus closed fractures. A) SF-36 Physical Component Score. B) SF-36 Mental Component Score. C) SMFA Dysfunction Index. D) SMFA Bothersome Index
See this image and copyright information in PMC

References

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