Tightrope or 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

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2018-04-30

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.

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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.

Conditions

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Syndesmotic Injury of the Ankle

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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Tightrope

Treatment with Tightrope Syndesmosis Repair Kit

Group Type ACTIVE_COMPARATOR

Tightrope Syndesmosis Repair Kit

Intervention Type DEVICE

Tightrope Syndesmosis Repair Kit

Syndesmotic screw

Treatment with a quadricortical syndesmotic screw

Group Type ACTIVE_COMPARATOR

Syndesmotic screw

Intervention Type DEVICE

Quadricortical syndesmotic screw

Interventions

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Tightrope Syndesmosis Repair Kit

Intervention Type DEVICE

Syndesmotic screw

Quadricortical syndesmotic screw

Intervention Type DEVICE

Other Intervention Names

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Tightrope Syndesmosis Repair Kit, Arthrex; Naples, Florida Cortical screw; Synthes GmbH, Switzerland

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No