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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.
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.
CHA-Pavillon Enfant-Jésus
Québec, Quebec, Canada
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.
Time frame: 3 months after surgery
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.
Time frame: within one year following surgery
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.
Time frame: 2 weeks after surgery
Implant failure
Rate of implant failure (with or without a second surgery for removal) will be measured in each group.
Time frame: one year after surgery
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.
Time frame: 6 weeks after surgery
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.
Time frame: 12 weeks after surgery
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.
Time frame: 6 months after surgery
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.
Time frame: 12 months after surgery
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.
Time frame: 12 weeks after surgery
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.
Time frame: 6 months after surgery
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.
Time frame: 12 months after surgery
Return to professional activities
This measure will be determined in days after surgery, for rate of 50% and 100% of the usual work load.
Time frame: 3 months after surgery
Pain on visual analog scale (VAS)
Pain is described with the VAS, which ranges from 1 to 10.
Time frame: 12 weeks after surgery
Pain on VAS
Pain is described with the VAS, which ranges from 1 to 10.
Time frame: 12 weeks after surgery
Pain on VAS
Pain is described with the VAS, which ranges from 1 to 10.
Time frame: 12 months after surgery
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.
Time frame: 12 weeks after surgery
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.
Time frame: 6 months after surgery
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.
Time frame: 12 months after surgery
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.
Time frame: 12 weeks after surgery
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.
Time frame: 6 months after surgery
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.
Time frame: 12 months after surgery
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.
Time frame: 12 weeks after surgery
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.
Time frame: 6 months after surgery
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.
Time frame: 12 months after surgery
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