Status:
RECRUITING
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
Lead Sponsor:
Ostfold Hospital Trust
Collaborating Sponsors:
Sykehuset Innlandet HF
Helse Nord-Trøndelag HF
Conditions:
Ankle Fractures
Deltoid Ligament; Sprain (Strain) (Ankle)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 sho...
Detailed Description
During the last two decades less severe ankle fractures have been shown not to need operative treatment in general. The total number of ankle fracture surgeries has gone down. Therefore, surgically tr...
Eligibility Criteria
Inclusion
- Inclusion criteria; fluent in oral and written Norwegian language
- isolated Weber type B fractures and Weber B+ posterior malleolar Mason Molloy class I.
- 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
- assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
- 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
Exclusion
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2032
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06568276
Start Date
September 20 2024
End Date
July 1 2032
Last Update
August 13 2025
Active Locations (9)
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1
Oestfold Hospital Trust
Grålum, Postbox 300, Norway, N-1714
2
Ålesund Sjukhehus
Ålesund, Norway
3
Haukeland University Hospital
Bergen, Norway
4
Nordlandssykehuset Bodø
Bodø, Norway