Status:
COMPLETED
Open Reduction Syndesmosis Tightrope Versus Screw Fixation
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Orthopaedic Trauma Association
Conditions:
Ankle Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments. The goal of operative treatment is to reduce the ankle morti...
Detailed Description
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments. The goal of operative treatment is to reduce the ankle mortis...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female 18yrs with a diagnosis of a closed Weber C ankle (OTA 44.C1, 44.C2, 44.C3) fracture.
- Randomization and treatment of syndesmosis injury within 14 days of the date of injury.
- Demonstrates lateral subluxation of talus on x-ray or stress views. Talar shift \> 1mm or medial clear space widening ≥ 5mm (unstable)
- No history of previous severe ankle injury, pathologic fracture, ligamentous laxity, no prior diagnosis or current treatment of osteoporosis or metabolic bone disease.
- No concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
- No neuromuscular or sensory deficiency.
- Able to understand and complete assessments
- Provision of Informed Consent
- Exclusion Criteria
- Age \< 18 years
- Open fracture or pathological fracture.
- Talar shift \< 1mm or medial clear space widening \< 5mm (stable)
- Prior diagnosis or current treatment for osteoporosis or metabolic bone disease.
- Concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
- Prior diagnosis or treatment for neuromuscular disease or sensory deficiency (i.e. diabetic neuropathy).
- Likely problems, in the judgment of the investigator, with maintaining follow-up (i.e. patients with no fixed address, patients incapable of providing informed consent, prisoners etc.).
- Patients who are currently pregnant or planning to become pregnant during the study duration.
Exclusion
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT02199249
Start Date
April 1 2015
End Date
September 1 2017
Last Update
February 8 2018
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A4G5