Ankle Syndesmosis Rupture Clinical Trial
Official title:
Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture
| Verified date | December 2012 |
| Source | Hopital de l'Enfant-Jesus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | January 2012 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | CHA-Pavillon Enfant-Jésus | Québec | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Hopital de l'Enfant-Jesus | Arthrex, Inc. |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Olerud-Molander score | 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. | 3 months after surgery | No |
| Secondary | Rate of secondary 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. | within one year following surgery | No |
| Secondary | Radiological loss of reduction | 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. |
2 weeks after surgery | No |
| Secondary | Implant failure | Rate of implant failure (with or without a second surgery for removal) will be measured in each group. | one year after surgery | No |
| Secondary | Radiological loss of reduction | Adequate reduction of the syndesmosis is evaluated on a simple X-ray in the 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. |
6 weeks after surgery | No |
| Secondary | Radiological loss of reduction | Adequate reduction of the syndesmosis is evaluated on a simple X-ray in the 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. |
12 weeks after surgery | No |
| Secondary | Radiological loss of reduction | Adequate reduction of the syndesmosis is evaluated on a simple X-ray in the 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. |
6 months after surgery | No |
| Secondary | Radiological loss of reduction | Adequate reduction of the syndesmosis is evaluated on a simple X-ray in the 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. |
12 months after surgery | No |
| Secondary | American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot | An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale. | 12 weeks after surgery | No |
| Secondary | AOFAS score of hindfoot | An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale. | 6 months after surgery | No |
| Secondary | AOFAS score of hindfoot | An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale. | 12 months after surgery | No |
| Secondary | Return to professional activities | This measure will be determined in days after surgery, for rate of 50% and 100% of the usual work load. | 3 months after surgery | No |
| Secondary | Pain on visual analog scale (VAS) | Pain is described with the VAS, which ranges from 1 to 10. | 12 weeks after surgery | No |
| Secondary | Pain on VAS | Pain is described with the VAS, which ranges from 1 to 10. | 12 weeks after surgery | No |
| Secondary | Pain on VAS | Pain is described with the VAS, which ranges from 1 to 10. | 12 months after surgery | No |
| Secondary | Range of motion | 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. | 12 weeks after surgery | No |
| Secondary | Range of motion | 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. | 6 months after surgery | No |
| Secondary | Range of motion | 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. | 12 months after surgery | No |
| Secondary | Muscular trophicity measure of the leg | 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. | 12 weeks after surgery | No |
| Secondary | Muscular trophicity measure of the leg | 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. | 6 months after surgery | No |
| Secondary | Muscular trophicity measure of the leg | 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. | 12 months after surgery | No |
| Secondary | Ankle circumference measure | 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. | 12 weeks after surgery | No |
| Secondary | Ankle circumference measure | 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. | 6 months after surgery | No |
| Secondary | Ankle circumference measure | 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. | 12 months after surgery | No |