Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Not Applicable

Completed

• Conditions: Ankle Fractures
• Interventions: Device: Tricortical 3.5 mm syndesmotic screw; Device: ZipTight suture endobutton

• Registration Number: NCT02930486
• Lead Sponsor: Vestre Viken Hospital Trust

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-10-09
• Study First Posted: 2016-10-12
• Primary Completion: 2017-09-30
• Study Completion: 2019-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Syndesmotic screw	Tricortical 3.5 mm syndesmotic screw	Tricortical 3.5 mm syndesmotic screw
ZipTight	ZipTight suture endobutton	ZipTight suture endobutton

Primary Outcome Measures

Name	Time	Method
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)	24 months	Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Baerum Hospital, Vestre Viken; 🇳🇴 Sandvika, Gjettum, Norway