Ankle Syndesmosis RuptureNCT01109303
Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture
A study testing TightRope System- Arthrex® / Dynamic Implant and Screw fixation - Synthes® / Static Implant in people with Ankle Syndesmosis Rupture, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Syndesmosis Rupture
- What is being tested?
- TightRope System- Arthrex® / Dynamic Implant and Screw fixation - Synthes® / Static Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of 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.
- Conditions
- Ankle Syndesmosis Rupture
- Being tested
- TightRope System- Arthrex® / Dynamic Implant, Screw fixation - Synthes® / Static Implant
- Keywords
- ankle fracture with syndesmotic ligament rupture, ankle syndesmosis rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TightRope System- Arthrex® / Dynamic ImplantProcedure or surgery
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 ImplantProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TightRope System | Active comparator | Patients are operated on using the TightRope implant by Arthrex. Receives: Procedure: TightRope System- Arthrex® / Dynamic Implant |
| Screw fixation implant | Active comparator | Patients are operated on using the rigid four-cortices 3,5 mm screw fixation by Synthes. Receives: Procedure: Screw fixation - Synthes® / Static Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (23)
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.
Measured: 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.
Measured: 2 weeks after surgery
Implant failure
Rate of implant failure (with or without a second surgery for removal) will be measured in each group.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after surgery
Pain on visual analog scale (VAS)
Pain is described with the VAS, which ranges from 1 to 10.
Measured: 12 weeks after surgery
Pain on VAS
Pain is described with the VAS, which ranges from 1 to 10.
Measured: 12 weeks after surgery
Pain on VAS
Pain is described with the VAS, which ranges from 1 to 10.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startOct 2008
- Primary completionFeb 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Syndesmosis RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital de l'Enfant-Jesus
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, Pelet Stephane, Hopital de l'Enfant-Jesus
- Investigators
- Stéphane Pelet, MD, PhD, Principal investigator, Hôpital Enfant-Jésus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109303
- Sponsor's protocol ID
- PEJ-446
- Status last verified
- Dec 2012
- First submitted
- 21 Apr 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture
- ClinicalTrials.gov ID
- NCT01109303
- Acronym / sponsor ID
- PEJ-446
- Conditions
- Ankle Syndesmosis Rupture
- Keywords
- ankle fracture with syndesmotic ligament rupture, ankle syndesmosis rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hopital de l'Enfant-JesusUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- Oct 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TightRope System | Active comparator | Procedure: TightRope System- Arthrex® / Dynamic ImplantPatients are operated on using the TightRope implant by Arthrex. |
| Screw fixation implant | Active comparator | Procedure: Screw fixation - Synthes® / Static ImplantPatients are operated on using the rigid four-cortices 3,5 mm screw fixation by Synthes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TightRope System- Arthrex® / Dynamic ImplantPatients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks. | Procedure or surgery | TightRope System |
| Screw fixation - Synthes® / Static ImplantPatients 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. | Procedure or surgery | Screw fixation implant |
Primary outcome
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.
23 secondary outcomes
Rate of secondary surgery
Time frame: within one year following surgery
Radiological loss of reduction
Time frame: 2 weeks after surgery
Implant failure
Time frame: one year after surgery
Radiological loss of reduction
Time frame: 6 weeks after surgery
Radiological loss of reduction
Time frame: 12 weeks after surgery
Radiological loss of reduction
Time frame: 6 months after surgery
Radiological loss of reduction
Time frame: 12 months after surgery
American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot
Time frame: 12 weeks after surgery
AOFAS score of hindfoot
Time frame: 6 months after surgery
AOFAS score of hindfoot
Time frame: 12 months after surgery
Return to professional activities
Time frame: 3 months after surgery
Pain on visual analog scale (VAS)
Time frame: 12 weeks after surgery
Pain on VAS
Time frame: 12 weeks after surgery
Pain on VAS
Time frame: 12 months after surgery
Range of motion
Time frame: 12 weeks after surgery
Range of motion
Time frame: 6 months after surgery
Range of motion
Time frame: 12 months after surgery
Muscular trophicity measure of the leg
Time frame: 12 weeks after surgery
Muscular trophicity measure of the leg
Time frame: 6 months after surgery
Muscular trophicity measure of the leg
Time frame: 12 months after surgery
Ankle circumference measure
Time frame: 12 weeks after surgery
Ankle circumference measure
Time frame: 6 months after surgery
Ankle circumference measure
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Pelet, MD, PhD principal investigator
Hôpital Enfant-Jésus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TightRope System- Arthrex® / Dynamic Implant and Screw fixation - Synthes® / Static Implant in people with Ankle Syndesmosis Rupture, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olerud-Molander score (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.