Clinical trial NCT01109303: Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture
Official title: Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Syndesmosis Rupture
Keywords: ankle fracture with syndesmotic ligament rupture
ankle syndesmosis rupture
Lead sponsor: Hopital de l'Enfant-Jesus
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2010-04-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Olerud-Molander score
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Rate of secondary surgery
timeFrame: within one year following surgery
measure: Radiological loss of reduction
timeFrame: 2 weeks after surgery
measure: Implant failure
timeFrame: one year after surgery
measure: Radiological loss of reduction
timeFrame: 6 weeks after surgery
measure: Radiological loss of reduction
timeFrame: 12 weeks after surgery
measure: Radiological loss of reduction
timeFrame: 6 months after surgery
measure: Radiological loss of reduction
timeFrame: 12 months after surgery
measure: American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot
timeFrame: 12 weeks after surgery
measure: AOFAS score of hindfoot
timeFrame: 6 months after surgery
measure: AOFAS score of hindfoot
timeFrame: 12 months after surgery
measure: Return to professional activities
timeFrame: 3 months after surgery
measure: Pain on visual analog scale (VAS)
timeFrame: 12 weeks after surgery
measure: Pain on VAS
timeFrame: 12 weeks after surgery
measure: Pain on VAS
timeFrame: 12 months after surgery
measure: Range of motion
timeFrame: 12 weeks after surgery
measure: Range of motion
timeFrame: 6 months after surgery
measure: Range of motion
timeFrame: 12 months after surgery
measure: Muscular trophicity measure of the leg
timeFrame: 12 weeks after surgery
measure: Muscular trophicity measure of the leg
timeFrame: 6 months after surgery
measure: Muscular trophicity measure of the leg
timeFrame: 12 months after surgery
measure: Ankle circumference measure
timeFrame: 12 weeks after surgery
measure: Ankle circumference measure
timeFrame: 6 months after surgery
measure: Ankle circumference measure
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHA-Pavillon Enfant-Jésus
state: Quebec
Study officials:
affiliation: Hôpital Enfant-Jésus
name: Stéphane Pelet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: