Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Syndesmotic Injury of the Ankle Clinical Trial

— TIGHTROPE-SS  

Official title:

Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275924
• Other study ID #: TIGHTROPE-SS
• Status: Completed
• Phase: N/A
• First received: January 11, 2011
• Last updated: April 17, 2018
• Start date: January 2011
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Sykehuset Asker og Baerum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2018
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Syndesmotic Injury of the Ankle
• Wounds and Injuries

Intervention

Device:
• Tightrope Syndesmosis Repair Kit
Tightrope Syndesmosis Repair Kit
• Syndesmotic screw
Quadricortical syndesmotic screw

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo
Norway	Baerum Hospital, Vestre Viken	Rud

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset Asker og Baerum	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)	Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)	5 years
Secondary	Olerud-Molander Ankle (OMA) Score		5 years
Secondary	Dorsiflexion angle	According to Lindsjø	5 years
Secondary	Health-related quality of life (EQ-5D)		5 years
Secondary	CT measurements of syndesmotic distance		5 years