search
Back to results

Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture

Primary Purpose

Ankle Syndesmosis Rupture

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TightRope System- Arthrex® / Dynamic Implant
Screw fixation - Synthes® / Static Implant
Sponsored by
Hopital de l'Enfant-Jesus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Syndesmosis Rupture focused on measuring ankle fracture with syndesmotic ligament rupture, ankle syndesmosis rupture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHA-Pavillon Enfant-Jésus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TightRope System

Screw fixation implant

Arm Description

Patients are operated on using the TightRope implant by Arthrex.

Patients are operated on using the rigid four-cortices 3,5 mm screw fixation by Synthes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Implant failure
Rate of implant failure (with or without a second surgery for removal) will be measured in each group.
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.
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.
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.
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.
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.
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.
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.
Return to professional activities
This measure will be determined in days after surgery, for rate of 50% and 100% of the usual work load.
Pain on visual analog scale (VAS)
Pain is described with the VAS, which ranges from 1 to 10.
Pain on VAS
Pain is described with the VAS, which ranges from 1 to 10.
Pain on VAS
Pain is described with the VAS, which ranges from 1 to 10.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 21, 2010
Last Updated
December 19, 2012
Sponsor
Hopital de l'Enfant-Jesus
Collaborators
Arthrex, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01109303
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital de l'Enfant-Jesus
Collaborators
Arthrex, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Syndesmosis Rupture
Keywords
ankle fracture with syndesmotic ligament rupture, ankle syndesmosis rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TightRope System
Arm Type
Active Comparator
Arm Description
Patients are operated on using the TightRope implant by Arthrex.
Arm Title
Screw fixation implant
Arm Type
Active Comparator
Arm Description
Patients are operated on using the rigid four-cortices 3,5 mm screw fixation by Synthes.
Intervention Type
Procedure
Intervention Name(s)
TightRope System- Arthrex® / Dynamic Implant
Intervention Description
Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.
Intervention Type
Procedure
Intervention Name(s)
Screw fixation - Synthes® / Static Implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Olerud-Molander score
Description
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
Secondary Outcome Measure Information:
Title
Rate of secondary surgery
Description
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
Title
Radiological loss of reduction
Description
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
Title
Implant failure
Description
Rate of implant failure (with or without a second surgery for removal) will be measured in each group.
Time Frame
one year after surgery
Title
Radiological loss of reduction
Description
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
Title
Radiological loss of reduction
Description
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
Title
Radiological loss of reduction
Description
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
Title
Radiological loss of reduction
Description
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
Title
American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot
Description
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
Title
AOFAS score of hindfoot
Description
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
Title
AOFAS score of hindfoot
Description
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
Title
Return to professional activities
Description
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
Title
Pain on visual analog scale (VAS)
Description
Pain is described with the VAS, which ranges from 1 to 10.
Time Frame
12 weeks after surgery
Title
Pain on VAS
Description
Pain is described with the VAS, which ranges from 1 to 10.
Time Frame
12 weeks after surgery
Title
Pain on VAS
Description
Pain is described with the VAS, which ranges from 1 to 10.
Time Frame
12 months after surgery
Title
Range of motion
Description
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
Title
Range of motion
Description
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
Title
Range of motion
Description
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
Title
Muscular trophicity measure of the leg
Description
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
Title
Muscular trophicity measure of the leg
Description
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
Title
Muscular trophicity measure of the leg
Description
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
Title
Ankle circumference measure
Description
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
Title
Ankle circumference measure
Description
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
Title
Ankle circumference measure
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Pelet, MD, PhD
Organizational Affiliation
Hôpital Enfant-Jésus
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA-Pavillon Enfant-Jésus
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture

We'll reach out to this number within 24 hrs