Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
S16
1 other identifier
interventional
120
1 country
1
Brief Summary
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.
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 2016
Longer than P75 for not_applicable
1 active site
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, 2016
CompletedFirst Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedNovember 29, 2019
November 1, 2019
1.7 years
April 18, 2016
November 26, 2019
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)
24 months
Secondary Outcomes (5)
Manchester-Oxford Foot questionnaire (MOxFQ)
24 months
Dorsiflexion angle
24 months
Health-related quality of life (EQ-5D)
24 months
CT measurements of syndesmotic distance
24 months
VAS
24 months
Study Arms (2)
ZipTight
ACTIVE COMPARATORZipTight suture endobutton
Syndesmotic screw
ACTIVE COMPARATORTricortical 3.5 mm syndesmotic screw
Interventions
Eligibility Criteria
You may qualify if:
- to 70 years
- Acute syndesmotic injury with Weber type C fracture
You may not qualify if:
- Prior injury og the same ankle
- Severe injury of the same leg affecting rehabilitation
- Symptomatic osteoarthritis of same ankle
- open injury
- Decubital injury affecting surgical site
- Dementia or unable to sign informed consent
- neuropatic conditions affecting same leg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vestre Viken Hospital Trustlead
- Oslo University Hospitalcollaborator
- Ostfold Hospital Trustcollaborator
Study Sites (1)
Baerum Hospital, Vestre Viken
Sandvika, Gjettum, 1346, Norway
Related Publications (1)
Raeder BW, Stake IK, Madsen JE, Frihagen F, Jacobsen SB, Andersen MR, Figved W. Randomized trial comparing suture button with single 3.5 mm syndesmotic screw for ankle syndesmosis injury: similar results at 2 years. Acta Orthop. 2020 Dec;91(6):770-775. doi: 10.1080/17453674.2020.1818175. Epub 2020 Sep 10.
PMID: 32907456DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2016
First Posted
October 12, 2016
Study Start
January 1, 2016
Primary Completion
September 30, 2017
Study Completion
October 1, 2019
Last Updated
November 29, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share