This trial is active, not recruiting.

Condition syndesmotic injury of the ankle
Treatments tightrope syndesmosis repair kit, syndesmotic screw
Sponsor Sykehuset Asker og Baerum
Collaborator Oslo University Hospital
Start date January 2011
End date March 2015
Trial size 100 participants
Trial identifier NCT01275924, TIGHTROPE-SS


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Treatment with Tightrope Syndesmosis Repair Kit
tightrope syndesmosis repair kit Tightrope Syndesmosis Repair Kit, Arthrex; Naples, Florida
Tightrope Syndesmosis Repair Kit
(Active Comparator)
Treatment with a quadricortical syndesmotic screw
syndesmotic screw Cortical screw; Synthes GmbH, Switzerland
Quadricortical syndesmotic screw

Primary Outcomes

OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
time frame: 24 months

Secondary Outcomes

Olerud-Molander Ankle (OMA) Score
time frame: 24 months
Dorsiflexion angle
time frame: 24 months
Health-related quality of life (EQ-5D)
time frame: 24 months
CT measurements of syndesmotic distance
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.
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 and 24 months and clinical end-ponts/scores.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sykehuset Asker og Baerum.