Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-10-31

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.

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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.

Conditions

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Ankle Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZipTight

ZipTight suture endobutton

Group Type ACTIVE_COMPARATOR

ZipTight suture endobutton

Intervention Type DEVICE

Zimmer Biomet ZipTight suture endobutton

Syndesmotic screw

Tricortical 3.5 mm syndesmotic screw

Group Type ACTIVE_COMPARATOR

Tricortical 3.5 mm syndesmotic screw

Intervention Type DEVICE

Depuy Synthes 3.5 mm screw

Interventions

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ZipTight suture endobutton

Zimmer Biomet ZipTight suture endobutton

Intervention Type DEVICE

Tricortical 3.5 mm syndesmotic screw

Depuy Synthes 3.5 mm screw

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No