Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury (TIGHTROPE-SS)

Sykehuset Asker og Baerum

Status: Completed

Conditions: Syndesmotic Injury of the Ankle

Treatments: Device: Syndesmotic screw; Device: Tightrope Syndesmosis Repair Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT01275924

TIGHTROPE-SS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Tightrope

Active Comparator group

Description:

Treatment with Tightrope Syndesmosis Repair Kit

Treatment:

Device: Tightrope Syndesmosis Repair Kit

Syndesmotic screw

Active Comparator group

Description:

Treatment with a quadricortical syndesmotic screw

Treatment:

Device: Syndesmotic screw