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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01275924
First Posted: January 13, 2011
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Wender Figved, Sykehuset Asker og Baerum
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.

Further study details as provided by Wender Figved, Sykehuset Asker og Baerum:

Primary Outcome Measures:
  • OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score) [ Time Frame: 24 months ]
    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 ]
  • Dorsiflexion angle [ Time Frame: 24 months ]
    According to Lindsjø

  • Health-related quality of life (EQ-5D) [ Time Frame: 24 months ]
  • CT measurements of syndesmotic distance [ Time Frame: 24 months ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: March 2018
Primary Completion Date: March 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275924


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0407
Baerum Hospital, Vestre Viken
Rud, Norway, 1351
Sponsors and Collaborators
Sykehuset Asker og Baerum
Oslo University Hospital
Investigators
Study Director: Wender Figved, MD, PhD Baerum Hospital, Vestre Viken, Norway
  More Information

Responsible Party: Wender Figved, MD PhD, Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier: NCT01275924     History of Changes
Other Study ID Numbers: TIGHTROPE-SS
First Submitted: January 11, 2011
First Posted: January 13, 2011
Last Update Posted: October 13, 2016
Last Verified: October 2016

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

Additional relevant MeSH terms:
Wounds and Injuries
Ankle Injuries
Leg Injuries