Skip to main content
OpenTrials
Completed

NCT Number: NCT01109303

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankle Syndesmosis Rupture

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHA-Pavillon Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TightRope System- Arthrex® / Dynamic Implant

Procedure

Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.

Screw fixation - Synthes® / Static Implant

Procedure

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 outcomes

  1. Olerud-Molander score

    Time frame: 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 outcomes

  1. Rate of secondary surgery

    Time frame: 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.

  2. Radiological loss of reduction

    Time frame: 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.

  3. Implant failure

    Time frame: one year after surgery

    Rate of implant failure (with or without a second surgery for removal) will be measured in each group.

  4. Radiological loss of reduction

    Time frame: 6 weeks after surgery

    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.

  5. Radiological loss of reduction

    Time frame: 12 weeks after surgery

    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. Radiological loss of reduction

    Time frame: 6 months after surgery

    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.

  7. Radiological loss of reduction

    Time frame: 12 months after surgery

    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.

  8. American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot

    Time frame: 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.

  9. AOFAS score of hindfoot

    Time frame: 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.

  10. AOFAS score of hindfoot

    Time frame: 12 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.

  11. Return to professional activities

    Time frame: 3 months after surgery

    This measure will be determined in days after surgery, for rate of 50% and 100% of the usual work load.

  12. Pain on visual analog scale (VAS)

    Time frame: 12 weeks after surgery

    Pain is described with the VAS, which ranges from 1 to 10.

  13. Pain on VAS

    Time frame: 12 weeks after surgery

    Pain is described with the VAS, which ranges from 1 to 10.

  14. Pain on VAS

    Time frame: 12 months after surgery

    Pain is described with the VAS, which ranges from 1 to 10.

  15. Range of motion

    Time frame: 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.

  16. Range of motion

    Time frame: 6 months 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.

  17. Range of motion

    Time frame: 12 months 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.

  18. Muscular trophicity measure of the leg

    Time frame: 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.

  19. Muscular trophicity measure of the leg

    Time frame: 6 months 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.

  20. Muscular trophicity measure of the leg

    Time frame: 12 months 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.

  21. Ankle circumference measure

    Time frame: 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.

  22. Ankle circumference measure

    Time frame: 6 months 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.

  23. Ankle circumference measure

    Time frame: 12 months 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.

Sponsors and collaborators

Lead sponsor

Hopital de l'Enfant-Jesus

Other

Collaborators

  • Arthrex, Inc.

Registry information

Official study title

Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Apr 23, 2010
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.