Repairing the deltoid ligament in unstable ankle fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Esten Konstad Haanæs, MD
• Email: estenkh@gmail.com
• Phone: +4799789013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.