• Renan C Castillo, Ellen J Mackenzie, Michael J Bosse, and LEAP Study Group.
• Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland 21205, USA. rcastill@jhsph.edu
• J Trauma. 2011 Dec 1;71(6):1726-31.

BackgroundThe ideal length of follow-up for orthopedic trauma research studies is unknown. This study compares 1- and 2-year complications, clinical recovery, and functional outcomes from a large prospective clinical study.MethodsPatients (n = 336) with limb threatening unilateral lower extremity injuries were followed at the 12, 24, and 84 months. Major outcomes observed were complications requiring hospital re-admission, fracture and wound healing, attainment of full weight bearing status, return to work, and self-reported functional outcome using the Sickness Impact Profile.ResultsThe rate of newly observed complications beyond year 1 was small, ranging from 0 to <2%. In addition, 85% to 90% of the clinical recovery outcomes were attained by 1 year, and patients not achieving clinical recovery during the first year had significantly worse functional outcomes. Only 5% of patients returned to work between 1 year and 2 years. Although, a substantial number of patients achieved functional recovery between 1 year and 2 years, of the patients not achieving functional recovery at year 1, 85% of those who would go on to achieve functional recovery during the second year could be predicted using year 1 data.ConclusionsAlthough 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.

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