Status:
COMPLETED
Ankle Fracture vs Ankle Fracture-Dislocation
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Ankle Fractures
Eligibility:
All Genders
18+ years
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 a...
Detailed 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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02198768
Start Date
September 1 2012
End Date
January 1 2017
Last Update
April 25 2022
Active Locations (1)
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1
Carolinas Medical Center- Main
Charlotte, North Carolina, United States, 28204