Taylor Spatial Frame or Reamed Intramedullary Nailing for Closed Fractures of the Tibial Shaft: A Randomized Controlled Trial.

OBJECTIVES

To compare a modern ring fixator [Taylor Spatial Frame (TSF)] and reamed intramedullary nailing (IMN) for the treatment of closed tibial shaft fractures.

DESIGN

Randomized controlled trial.

SETTING

Two university hospitals.

PATIENTS

Patients between 18 and 70 years of age surgically treated for an acute tibial shaft fracture.

INTERVENTION

TSF (n = 31) versus a reamed intramedullary nail (n = 32). The patients were followed up for 2 years.

MAIN OUTCOME MEASUREMENTS

The physical component summary of Short Form 36 (SF-36) at 2 years was the primary outcome measure. Secondary outcomes included the other components of the SF-36, pain assessed by a visual analogue scale (VAS), complications, and resource consumption.

RESULTS

The mean age was 43 years (SD 14.0), and 42 (67%) were men. The physical component summary at 2 years was 52.4 (SD 6.3) in the TSF group and 53.3 (SD 8.0) in the IMN group (P = 0.35). There were modest differences in the other SF-36 scores during the follow-up period. Up to and including 12 months, the TSF group had less knee pain [at 12 months: VAS 0.5 (SD 1.2) vs. VAS 2.4 (SD 2.2; P < 0.001)], but this was not statistically significant at 24 months [VAS 0.7 (SD 1.4) vs. VAS 1.5 (SD 2.0; P = 0.11)]. Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001]. The number of other complications was similar between the groups.

CONCLUSIONS

Both TSF and IMN provided good clinical results. TSF had more pin-track infections but less knee pain the first year.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.