Clinical Trial: Ankle Fracture vs Ankle Fracture-Dislocation
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Functional Outcome After Ankle Fractures and Ankle Fracture-Dislocations: A Prospective Study
Brief Summary: The purpose of this study is to compare outcomes of patients with an ankle fracture to those with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for patients sustaining ankle fracture dislocations are poorer than those without dislocation.
Detailed Summary: Orthopaedic literature has very limited data regarding outcomes following ankle fracture dislocations. Increased knowledge of the long-term consequences of these injuries could usher in changes to treatment paradigms, potentially resulting in improved outcomes. Thirty patients will be enrolled into two arms of this prospective study: isolated ankle fractures and ankle fracture dislocations. Patients will be followed through their operative and postoperative course and clinical and radiographic assessments will be analyzed. We plan to compare the clinical, radiographic, and functional outcomes of patients with ankle fractures to those with ankle fracture-dislocations. We also plan to identify factors that contribute to or predict poor clinical, functional, and/or radiographic outcomes in patients with ankle fractures and fracture-dislocations.
Sponsor: Carolinas Healthcare System
Current Primary Outcome: Change in Functional Outcome [ Time Frame: 6, 12, and 24 months ]
Clinical and functional outcomes will be measured using the Foot and Ankle Ability Measure (FAAM) and the Short Form Musculoskeletal Functional Assessment (SMFA).
Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.
Original Primary Outcome: Same as current
Current Secondary Outcome: Radiographic Outcome [ Time Frame: 24 month ]
Original Secondary Outcome: Same as current
Information By: Carolinas Healthcare System
Dates:
Date Received: March 28, 2013
Date Started: September 2012
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017
