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

This study is currently recruiting participants.
Verified August 2011 by Sykehuset Asker og Baerum
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by:
Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier:
NCT01275924
First received: January 11, 2011
Last updated: August 12, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Syndesmotic Injury of the Ankle
 Device: Tightrope Syndesmosis Repair Kit
Device: Syndesmotic screw

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by Sykehuset Asker og Baerum:

Primary Outcome Measures:
  • OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)


Secondary Outcome Measures:
  • Olerud-Molander Ankle (OMA) Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Dorsiflexion angle [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    According to Lindsjø

  • Health-related quality of life (EQ-5D) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • CT measurements of syndesmotic distance [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tightrope
Treatment with Tightrope Syndesmosis Repair Kit
 Device: Tightrope Syndesmosis Repair Kit
Tightrope Syndesmosis Repair Kit
Other Name: Tightrope Syndesmosis Repair Kit, Arthrex; Naples, Florida
Active Comparator: Syndesmotic screw
Treatment with a quadricortical syndesmotic screw
 Device: Syndesmotic screw
Quadricortical syndesmotic screw
Other Name: Cortical screw; Synthes GmbH, Switzerland

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 and 24 months and clinical end-ponts/scores.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275924

Contacts
Contact: Mette Andersen, MD +4790041142 metterenate@hotmail.com
Contact: Wender Figved, MD, PhD +4767809400 wender@mac.com

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0407
Contact: Mette Andersen, MD     +4790041142     metterenate@hotmail.com    
Principal Investigator: Mette Andersen, MD            
Baerum Hospital, Vestre Viken Recruiting
Rud, Norway, 1351
Contact: Wender Figved, MD, PhD     +4767809400     wender@mac.com    
Principal Investigator: Wender Figved, MD, PhD            
Sponsors and Collaborators
Sykehuset Asker og Baerum
Oslo University Hospital
Investigators
Study Director: Wender Figved, MD, PhD Baerum Hospital, Vestre Viken, Norway
  More Information

No publications provided

Responsible Party: Wender Figved, MD, PhD, Baerum Sykehus, Vestre Viken, Norway
ClinicalTrials.gov Identifier: NCT01275924     History of Changes
Other Study ID Numbers: TIGHTROPE-SS
Study First Received: January 11, 2011
Last Updated: August 12, 2011
Health Authority: Norway: Norwegian Institute of Public Health
Norway: Directorate of Health

Keywords provided by Sykehuset Asker og Baerum:
Syndesmosis
Injury
Ankle
Fracture

ClinicalTrials.gov processed this record on May 23, 2013