Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Not Applicable

Completed

• Conditions: Syndesmotic Injury of the Ankle
• Interventions: Device: Syndesmotic screw; Device: Tightrope Syndesmosis Repair Kit

• Registration Number: NCT01275924
• Lead Sponsor: Sykehuset Asker og Baerum

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2015-03
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Syndesmotic screw	Syndesmotic screw	Treatment with a quadricortical syndesmotic screw
Tightrope	Tightrope Syndesmosis Repair Kit	Treatment with Tightrope Syndesmosis Repair Kit

Primary Outcome Measures

Name	Time	Method
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)	5 years	Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)

Secondary Outcome Measures

Name	Time	Method
Dorsiflexion angle	5 years	According to Lindsjø
Olerud-Molander Ankle (OMA) Score	5 years
Health-related quality of life (EQ-5D)	5 years
CT measurements of syndesmotic distance	5 years

Trial Locations

Locations (2)

Oslo University Hospital; 🇳🇴 Oslo, Norway

Baerum Hospital, Vestre Viken; 🇳🇴 Rud, Norway