title: Orthopaedic trauma clinical research: is 2-year follow-up necessary? Results from a longitudinal study of severe lower extremity trauma.
abstract: BACKGROUND
  The 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.
  
  
  METHODS
  Patients (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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  Although 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.
authors.affiliation: Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland 21205, USA. rcastill@jhsph.edu
authors.forename: Renan C
authors.initials: RC
authors.lastname: Castillo
authors.forename: Ellen J
authors.initials: EJ
authors.lastname: Mackenzie
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Bosse
mesh_terms: D000328:Adult; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006302:Health Services Research; D006801:Humans; D015601:Injury Severity Score; D007869:Leg Injuries / Q000175:diagnosis* / Q000601:surgery*; D023821:Limb Salvage; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D019637:Orthopedic Procedures / Q000009:adverse effects / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D020127:Recovery of Function; D018434:Sickness Impact Profile; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult