Session X1 - Tibia
Orthopaedic Trauma Clinical Research: Is Two Year Follow-up Necessary?
Purpose: The expectation of 2-year follow-up often makes prospective clinical orthopaedic trauma research difficult and expensive. This study will compare the 1 and 2-year complications, clinical recovery, and functional outcomes from a large prospective clinical study to determine if the results or conclusions differ between the 1- and the 2-year data.
Methods: Patients (n=336) with unilateral lower extremity limb-threatening injuries and a subgroup of tibial diaphyseal fractures (n=122) were followed at 12 and 24 months. Major complications requiring hospital readmission, fracture and wound healing, full weight bearing, return to work, and self-reported functional outcomes (SIP) were assessed at each time point. We determined the new complication incidence and the change in clinical recovery after the first year. Differences in the SIP scores, time to full weight bearing, and first return to work were also compared at the 1- and 2-year time points.
Results: 85% of the clinical functional outcomes were attained by 1 year. Of the 15% that were not observed at 1 year, 85% could be predicted using data observed at 1 year. The conclusions of the limb outcome and the tibia fracture cohort analyses were the same at the 1- and 2-year points. The rate of newly observed complications beyond 1 year was small, ranging from 0 to <2%. Only 5% of patients returned to work between 1 and 2 years. 8% of fractures not healed at 1 year healed in the second year, and only 9% of the patients advanced to full weight bearing in the second year.
Conclusions/Significance: Successfully competing for clinical orthopaedic trauma research funding typically demands a follow-up strategy to 2 years. While long-term follow-up provides a more complete picture of final outcomes and rate of recovery, follow-up beyond 1 year is difficult and expensive. In our study, it accounted for 20% of the total cost. The analysis of our data suggests that 1-year data were sufficient to address our major study hypotheses. Clinical orthopaedic trauma research efforts could benefit from the recognition that a 1-year follow-up strategy may be efficacious.