Ankle Syndesmosis Rupture
Conditions
Keywords
ankle fracture with syndesmotic ligament rupture, ankle syndesmosis rupture
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.
Interventions
PROCEDURETightRope System- Arthrex® / Dynamic Implant
Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.
PROCEDUREScrew fixation - Synthes® / Static Implant
Patients are operated on using a static implant, the rigid four-cortices 3,5 mm screw fixation by Synthes®. The ankle is immobilized in a plaster boot for 6 weeks.
Sponsors
Arthrex, Inc.
Hopital de l'Enfant-Jesus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Olerud-Molander score | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiological loss of reduction | 2 weeks after surgery | Adequate reduction of the syndesmosis is evaluated on a simple X-ray in the anteroposterior (AP) and mortise views; the clear space is the distance between the medial side of fibula and the incisural surface of tibia (1 cm above tibial pilon) and cannot be more than 6 mm. Rate of loss of reduction and the range of this loss over 6 mm will be calculated in each group. |
| Implant failure | one year after surgery | Rate of implant failure (with or without a second surgery for removal) will be measured in each group. |
| American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot | 12 weeks after surgery | An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale. |
| AOFAS score of hindfoot | 6 months after surgery | An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale. |
| Return to professional activities | 3 months after surgery | This measure will be determined in days after surgery, for rate of 50% and 100% of the usual work load. |
| Rate of secondary surgery | within one year following surgery | To measure the rate of secondary surgery due to infection or implant removal. Every secondary surgery during the following year counts, even for the same patient. |
| Pain on VAS | 12 weeks after surgery | Pain is described with the VAS, which ranges from 1 to 10. |
| Range of motion | 12 weeks after surgery | With a goniometer, a measure of the dorsal flexion (normal value 20°) and plantar flexion (40°) will be taken. Inversion and eversion will be measured according to this scale: + = weak ; ++ = middle ; +++ = complete. |
| Muscular trophicity measure of the leg | 12 weeks after surgery | This measure is taken with a metric band 15 cm under the inferior patellar pole and must be compared to normal side. It is defined in cm with a precision of 0.5 cm. A ratio injured side/normal side will be calculated. |
| Ankle circumference measure | 12 weeks after surgery | This measure is taken with a metric band at the bimalleolar level and must be compared to normal side. It is defined in cm with a precision of 0.5 cm. A ratio injured side/normal side will be calculated. |
| Pain on visual analog scale (VAS) | 12 weeks after surgery | Pain is described with the VAS, which ranges from 1 to 10. |
Countries
Canada
Outcome results
None listed