Frede Frihagen1, Jan E Madsen1,2, Mikael Sundfeldt3, Gunnar B Flugsrud1, Joakim S Andreassen1, Mette R Andersen4, Geir S Andreassen1. 1. Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway. 2. Institute of Clinical Medicine, University of Oslo, Oslo, Norway. 3. Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, Sweden; and. 4. Department of Orthopaedic Surgery, Baerum Hospital, Vestre Viken Hospital Trust, Norway.
Abstract
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.
RCT Entities:
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.