The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
NCT ID: NCT06568276
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-09-20
2032-07-01
Brief Summary
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Detailed Description
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The investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures. This will be performed as a multicentre randomized controlled study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional treatment
Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus only
No interventions assigned to this group
Additional deltoid ligament suture
Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus and additional deep deltoid ligament suture
Additional deep deltoid ligament suture
The deep deltoid ligament will be sutured through a curved incision lifting the tibialis posterior tendon out to be sutured back after tying the ligament to an anchor in the talus.
Interventions
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Additional deep deltoid ligament suture
The deep deltoid ligament will be sutured through a curved incision lifting the tibialis posterior tendon out to be sutured back after tying the ligament to an anchor in the talus.
Eligibility Criteria
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Inclusion Criteria
* Initial medial clear space (MCS)\>=7mm or weightbearing x-ray evaluated as unstable or primary reposition after fracture dislocation.
* Pre-injury walking ability without aids.
Exclusion Criteria
* previous history of ipsilateral ankle fracture or ipsilateral major ankle-/foot surgery.
* open fx Gustilo Anderson II or more, multi-trauma and pathologic fracture.
* neuropathies and generalized joint disease such as Rheumatoid Arthritis or other more severe condition in same extremity
* fixation of tibial fragment or syndesmotic screw or suture button planned prior to surgery
18 Years
65 Years
ALL
No
Sponsors
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Sykehuset Innlandet HF
OTHER
Helse Nord-Trøndelag HF
OTHER
Helse-Bergen HF
OTHER
Norwegian Institute of Public Health
OTHER_GOV
Helse Stavanger HF
OTHER_GOV
Trondheim University Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Alesund Hospital
OTHER
Nordlandssykehuset HF
OTHER
Ostfold Hospital Trust
OTHER
Responsible Party
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Principal Investigators
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Frede Jon Frihagen, MD, PhD
Role: STUDY_DIRECTOR
Oestfold Hospital Trust
Locations
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Oestfold Hospital Trust
Grålum, Postbox 300, Norway
Ålesund Sjukhehus
Ålesund, , Norway
Haukeland University Hospital
Bergen, , Norway
Nordlandssykehuset Bodø
Bodø, , Norway
Sykehuset Innlandet Elverum
Elverum, , Norway
Sykehuset Innlandet Gjøvik
Gjøvik, , Norway
Sykehuset Levanger
Levanger, , Norway
Oslo University Hospital Ullevål/Aker
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Study protocol general august 2024
Document Type: Study Protocol and Statistical Analysis Plan: Study protocol update january 2025
Other Identifiers
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2024104
Identifier Type: -
Identifier Source: org_study_id
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