Repairing the deltoid ligament in unstable ankle fractures
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-reported Functional Outcome and Radiological Stability Measurements
This study tests whether sewing the deep deltoid ligament in adults with unstable Weber B ankle fractures leads to better function and less long-term arthritis than fixing the outer ankle bone alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ostfold Hospital Trust Academic / other |
| Locations | 9 sites (Grålum, Postbox 300 and 8 other locations) |
| Trial ID | NCT06568276 on ClinicalTrials.gov |
What this trial studies
This is a multicenter randomized trial enrolling adults with isolated unstable Weber B ankle fractures to compare standard lateral malleolus fixation with or without additional deep deltoid ligament suture. Participants are randomly assigned to receive lateral osteosynthesis alone or lateral fixation plus deltoid ligament repair, and outcomes include functional scores and imaging for post-traumatic arthritis over follow-up. Key eligibility includes isolated Weber B (and certain Weber B+ posterior malleolar) fractures with medial clear space >=7 mm or other signs of instability and pre-injury independent walking. The trial is conducted at several Norwegian hospitals and excludes patients with major open fractures, neuropathies, prior ipsilateral major ankle surgery, or planned syndesmotic fixation.
Who should consider this trial
Good fit: Adults who previously walked without aids and present with an isolated unstable Weber B (or specified Weber B+ posterior malleolar) ankle fracture with widened medial clear space or unstable weightbearing films, and who are fluent in Norwegian, are ideal candidates.
Not a fit: Patients with open Gustilo-Anderson II+ fractures, multi-trauma, neuropathies, inflammatory joint disease, prior major ipsilateral ankle surgery, or those who require planned tibial fragment fixation or syndesmotic hardware are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, adding deltoid ligament repair could improve ankle function and reduce the risk of long-term osteoarthritis and additional procedures.
How similar studies have performed: Cadaver studies and small clinical series suggest deltoid ligament repair increases mechanical stability and may improve outcomes, but large randomized clinical evidence is not yet available.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Grålum, Postbox 300 and 8 other locations
- Oestfold Hospital Trust — Grålum, Postbox 300, Norway (Recruiting)
- Ålesund Sjukhehus — Ålesund, Norway (Recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Nordlandssykehuset Bodø — Bodø, Norway (Recruiting)
- Sykehuset Innlandet Elverum — Elverum, Norway (Recruiting)
- Sykehuset Innlandet Gjøvik — Gjøvik, Norway (Recruiting)
- Sykehuset Levanger — Levanger, Norway (Recruiting)
- Oslo University Hospital Ullevål/Aker — Oslo, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
Study contacts
- Study coordinator: Esten Konstad Haanæs, MD
- Email: estenkh@gmail.com
- Phone: +4799789013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.