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

This study has been completed.
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Pelet Stephane, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT01109303
First received: April 21, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Ankle Syndesmosis Rupture
Procedure: TightRope System- Arthrex® / Dynamic Implant
Procedure: Screw fixation - Synthes® / Static Implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture

Further study details as provided by Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • Olerud-Molander score [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: within one year following surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: No ]

    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    Rate of implant failure (with or without a second surgery for removal) will be measured in each group.

  • Radiological loss of reduction [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    Pain is described with the VAS, which ranges from 1 to 10.

  • Pain on VAS [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    Pain is described with the VAS, which ranges from 1 to 10.

  • Pain on VAS [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Pain is described with the VAS, which ranges from 1 to 10.

  • Range of motion [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 70
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TightRope System
Patients are operated on using the TightRope implant by Arthrex.
Procedure: TightRope 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.
Active Comparator: Screw fixation implant
Patients are operated on using the rigid four-cortices 3,5 mm screw fixation by Synthes.
Procedure: Screw 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109303

Locations
Canada, Quebec
CHA-Pavillon Enfant-Jésus
Québec, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Arthrex, Inc.
Investigators
Principal Investigator: Stéphane Pelet, MD, PhD Hôpital Enfant-Jésus
  More Information

No publications provided

Responsible Party: Pelet Stephane, Dr Stephane Pelet MD, PhD Orthopedic surgeon, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier: NCT01109303     History of Changes
Other Study ID Numbers: PEJ-446
Study First Received: April 21, 2010
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hopital de l'Enfant-Jesus:
ankle fracture with syndesmotic ligament rupture
ankle syndesmosis rupture

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014