This trial has been completed.

Condition ankle fractures
Sponsor Carolinas Healthcare System
Start date September 2012
End date November 2016
Trial size 80 participants
Trial identifier NCT02198768, 06-12-03A


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients with isolated ankle fractures.
Patients with ankle fracture-dislocations.

Primary Outcomes

Change in Functional Outcome
time frame: 6, 12, and 24 months

Secondary Outcomes

Radiographic Outcome
time frame: 24 month

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Patients who sustain an isolated bi-malleolar or trimalleolar ankle fracture or an ankle fracture-dislocation requiring open reduction internal fixation - Patients ages 18 and over - The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study - Open and closed fractures (excluding Gustilo grade 3) - English must be patient's primary language Exclusion Criteria: - Previous injury or significant osteoarthritis to the affected ankle - Current ipsilateral or contralateral lower extremity injury with the exception of a contralateral ankle fracture or fracture-dislocation - Retained hardware from a previous injury at or around the tibia-talar joint of the affected extremity - Patients under the age of 18 - History of inflammatory arthropathy - Traumatic Brain Injury or Spinal Cord Injury preventing weightbearing on the lower extremities - The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements - Patients with Gustilo grade 3B and 3C open fractures

Additional Information

Official title Functional Outcome After Ankle Fractures and Ankle Fracture-Dislocations: A Prospective Study
Principal investigator Michael Bosse, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Carolinas Healthcare System.