Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Study Overview
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Brief Summary
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Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.

Detailed Description
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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 ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal. patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.

Official Title
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Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Conditions
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Ankle Fractures

Intervention / Treatment
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* Device: ZipTight suture endobutton
* Device: Tricortical 3.5 mm syndesmotic screw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 70 years Acute syndesmotic injury with Weber type C fracture Exclusion Criteria: Prior injury og the same ankle Severe injury of the same leg affecting rehabilitation Symptomatic osteoarthritis of same ankle open injury Decubital injury affecting surgical site Dementia or unable to sign informed consent neuropatic 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: ZipTight<br>ZipTight suture endobutton | Device: ZipTight suture endobutton<br>* Zimmer Biomet ZipTight suture endobutton<br>|
| Active Comparator: Syndesmotic screw<br>Tricortical 3.5 mm syndesmotic screw | Device: Tricortical 3.5 mm syndesmotic screw<br>* Depuy Synthes 3.5 mm screw<br>|

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) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manchester-Oxford Foot questionnaire (MOxFQ) |  | 24 months | 
| Dorsiflexion angle | according to Lindsjø | 24 months | 
| Health-related quality of life (EQ-5D) |  | 24 months | 
| CT measurements of syndesmotic distance |  | 24 months | 
| VAS | visual analogue scale | 24 months | 

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