Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Study Overview
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Brief Summary
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Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.

Detailed Description
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Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.

Official Title
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Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.

Conditions
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Syndesmotic Injury of the Ankle

Intervention / Treatment
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* Device: Tightrope Syndesmosis Repair Kit
* Device: Syndesmotic screw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 70 years Acute syndesmotic injury with or without Weber type C fracture Exclusion Criteria: Prior injury of the same ankle Severe injury of same leg affecting rehabilitation Symptomatic osteoarthritis of same ankle Open injury Decubital injury affecting surgical site Dementia or unable to sign informed consent Neuropathic conditions affecting same leg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tightrope<br>Treatment with Tightrope Syndesmosis Repair Kit | Device: Tightrope Syndesmosis Repair Kit<br>* Tightrope Syndesmosis Repair Kit<br>* Other names: Tightrope Syndesmosis Repair Kit, Arthrex; Naples, Florida;|
| Active Comparator: Syndesmotic screw<br>Treatment with a quadricortical syndesmotic screw | Device: Syndesmotic screw<br>* Quadricortical syndesmotic screw<br>* Other names: Cortical screw; Synthes GmbH, Switzerland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score) | Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Olerud-Molander Ankle (OMA) Score |  | 5 years | 
| Dorsiflexion angle | According to Lindsjø | 5 years | 
| Health-related quality of life (EQ-5D) |  | 5 years | 
| CT measurements of syndesmotic distance |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Syndesmosis, Injury, Ankle, Fracture