Actively Recruiting
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
Led by Ostfold Hospital Trust · Updated on 2025-08-13
120
Participants Needed
9
Research Sites
405 weeks
Total Duration
On this page
Sponsors
O
Ostfold Hospital Trust
Lead Sponsor
S
Sykehuset Innlandet HF
Collaborating Sponsor
AI-Summary
What this Trial Is About
Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (ADL) function. Improving outcome for this group may preserve some patients' ability to work and reduce community expenses.
CONDITIONS
Official Title
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fluent in oral and written Norwegian language
- Isolated Weber type B fractures or Weber B with posterior malleolar Mason Molloy class I
- Initial medial clear space (MCS) 7 mm or more, or unstable fracture by weightbearing x-ray, or primary reposition after fracture dislocation
- Ability to walk without aids before injury
You will not qualify if you...
- Assumed not compliant due to drug use, cognitive, or psychiatric disorders
- Previous ipsilateral ankle fracture or major ankle/foot surgery
- Open fracture Gustilo Anderson II or higher, multi-trauma, or pathologic fracture
- Neuropathies or generalized joint disease such as Rheumatoid Arthritis or severe conditions in the same limb
- Planned fixation of tibial fragment or syndesmotic screw or suture button before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Oestfold Hospital Trust
Grålum, Postbox 300, Norway, N-1714
Actively Recruiting
2
Ålesund Sjukhehus
Ålesund, Norway
Actively Recruiting
3
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
4
Nordlandssykehuset Bodø
Bodø, Norway
Actively Recruiting
5
Sykehuset Innlandet Elverum
Elverum, Norway
Actively Recruiting
6
Sykehuset Innlandet Gjøvik
Gjøvik, Norway
Actively Recruiting
7
Sykehuset Levanger
Levanger, Norway
Actively Recruiting
8
Oslo University Hospital Ullevål/Aker
Oslo, Norway
Actively Recruiting
9
Stavanger University Hospital
Stavanger, Norway
Actively Recruiting
Research Team
E
Esten Konstad Haanæs, MD
CONTACT
M
Marius Molund, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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