Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Olerud-Molander score
Study Overview
Brief Summary
Ankle fracture is frequent and its number is increasing. In Canada, surgical treatment of these lesions is advised and the options currently used all have in common a rigid fixation of the syndesmosis which results in residual stiffness and a high level of secondary surgery, mostly to remove the implant.
The purpose of the study is to compare the treatment of ankle syndesmotic rupture by a dynamic fixation to a static fixation suggesting that the dynamic fixation method will improve the Olerud-Molander functional score of more than 15 points at the 3 months follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •men or women ≥ 18 years-old;
- •ankle fracture type 44-C (AO classification) with an AP, lateral and mortise X-ray views of the ankle and an AP and lateral X-ray views of the leg;
- •open fractures (Gustilo I-IIIb) or closed;
- •trauma-surgery delay of less than 7 days;
- •consent form signed.
Exclusion Criteria
- •ankle fractures without syndesmotic lesion;
- •fracture associated with neuro-vascular lesions (Gustillo IIIc);
- •pathologic fracture;
- •fracture in a polytraumatized patient;
- •fracture of a bone in the ipsilateral leg;
- •men or women > 65 years-old;
- •chronic cardiac insufficiency (ejection fraction < 30%);
- •lower leg chronic venous insufficiency;
- •neuro-arthropathic foot (Charcot, diabetes, etc...);
- •body mass index ≥ 40;
- •past medical history of fracture of the same ankle;
- •medical conditions too serious for a surgery;
- •men or women unfit to consent;
- •any other conditions that make the examinator thinks that the follow up would be problematic.
Outcomes
Primary Outcomes
Olerud-Molander score
Time Frame: 3 months after surgery
The Olerud-Molander scoring scale was chosen because it adequately represents the ankle performance following surgery (trauma or elective basis). It comprises nine functional parameters which are concerned with primary complaints, the ability to perform simple tasks and the everyday life activities.
Secondary Outcomes
- Rate of secondary surgery(within one year following surgery)
- Radiological loss of reduction(12 months after surgery)
- Implant failure(one year after surgery)
- American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot(12 weeks after surgery)
- AOFAS score of hindfoot(12 months after surgery)
- Return to professional activities(3 months after surgery)
- Pain on visual analog scale (VAS)(12 weeks after surgery)
- Pain on VAS(12 months after surgery)
- Range of motion(12 months after surgery)
- Muscular trophicity measure of the leg(12 months after surgery)
- Ankle circumference measure(12 months after surgery)
Investigators
Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Hopital de l'Enfant-Jesus