Fri., 10/19/07 Tibia, Paper #22, 10:36 am OTA-2007
Functional, General, and Disability Outcomes after Tibial Nailing: A Randomized Trial
Mohit Bhandari, MD1 (n); Paul Tornetta, III, MD2 (n);
1McMaster University, Hamilton, Ontario, Canada;
2Boston Medical Center, Boston, Massachusetts, USA
Introduction: Tibial shaft fractures are a common injury. Tibial nailing is the current standard of care for these injuries, yet there is little information regarding the patient based outcomes after nailing. We sought to determine the 1-year patient-based outcomes and return to activities for patients with tibia fractures in a randomized trial of reamed and unreamed nail insertion. Additionally, we wished to determine the effect of having a closed, versus open fracture and an isolated injury, versus multiple injuries.
Methods: Over a 5-year period 1226 patients with 830 closed and 392 open tibial shaft fractures were entered into a randomized trial comparing reamed with unreamed tibial nail insertion in 29 trauma centers and had 1-year follow-up. The average age was 39 ± 16 years and 74% were male. Patient-based outcomes were determined using the validated SF-36 PCS, the SMFA, and a published activity return questionnaire. Outcomes were obtained during the initial hospitalization to reflect preinjury status, and then the same outcome instruments were used at the 2-week, 3-month, 6-month, and 1-year follow-up. Statistical analysis was performed as a stratified analysis comparing the groups with P <0.05 designated as significant.
Results: There was no difference in any outcome parameter for any time frame between the reamed and unreamed groups. The 1-year SF-36 PCS (a 100-point scale with a mean of 50 in the general population, higher is better) was 42.9 ± 11 and 43.5 ± 11 for the 2 groups as compared with 52.5 ± 9 and 53.1 ± 9 preinjury. The SMFA (100-point scale, higher is worse) at 1 year was 18 ± 17 and 17.5 ± 17 for the 2 groups as compared with 7.9 ± 13 and 7.7 ± 13 preinjury. As these results indicated no difference between the reamed and unreamed groups, the remaining analyses were done across groups. Closed fractures faired better then open fractures at 1 year for both scores—44.6 ± 11 versus 40 ± 11 for the SF-36 PCS (P <0.001, 95% confidence interval [CI] = 2.9-6.2) and 16.2 ± 17 versus 21.7 ± 18 for the SMFA (P <0.001, 95% CI = 2.9-8.2). Similarly, patients with isolated tibia fractures had superior outcomes to those who were multiply injured—44.7 ± 11 versus 40 ± 12 for the SF-36 PCS (P <0.001, 95%CI=3.0-6.3), and 14.8 ± 15 versus 23.8 ± 20 for the SMFA (P <0.001, 95% CI = 6.5-11.5). The activity questionnaire is summarized in the table for open, closed, isolated, multitrauma, and isolated closed fractures. Note that even the best results, seen in the isolated closed group, demonstrated only a 54% return to sporting activities and a 79% back to work rate.
Conclusion: In patients with tibial shaft fractures treated with intramedullary nails, patient-based outcomes are not related to reamed or unreamed insertion. Patients with open fractures and multiply injured patients had statistically worse outcomes, more dysfunction, and lower rates of return to work than the comparison patients with closed or isolated injury (P <0.001 for all comparisons). Patients sustaining tibial shaft injuries do not return to their preinjury status based on validated outcomes assessments or return to activity by 1 year after injury.
If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing.