Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury
TIGHTROPE-SS
1 other identifier
interventional
97
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 11, 2011
CompletedFirst Posted
Study publicly available on registry
January 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 18, 2018
April 1, 2018
4.2 years
January 11, 2011
April 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Olerud-Molander Ankle (OMA) Score
5 years
Dorsiflexion angle
5 years
Health-related quality of life (EQ-5D)
5 years
CT measurements of syndesmotic distance
5 years
Study Arms (2)
Tightrope
ACTIVE COMPARATORTreatment with Tightrope Syndesmosis Repair Kit
Syndesmotic screw
ACTIVE COMPARATORTreatment with a quadricortical syndesmotic screw
Interventions
Tightrope Syndesmosis Repair Kit
Quadricortical syndesmotic screw
Eligibility Criteria
You may qualify if:
- to 70 years
- Acute syndesmotic injury with or without Weber type C fracture
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sykehuset Asker og Baerumlead
- Oslo University Hospitalcollaborator
Study Sites (2)
Oslo University Hospital
Oslo, 0407, Norway
Baerum Hospital, Vestre Viken
Rud, 1351, Norway
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Wender Figved, MD, PhD
Baerum Hospital, Vestre Viken, Norway
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
January 11, 2011
First Posted
January 13, 2011
Study Start
January 1, 2011
Primary Completion
March 1, 2015
Study Completion
April 1, 2018
Last Updated
April 18, 2018
Record last verified: 2018-04