Comparing functional orthosis and cast immobilization for ankle fractures

Six Weeks Functional Orthosis Versus Cast Immobilization for Partially Unstable Weber B/SER4a Ankle Fractures - a Multicenter Randomized Non-inferiority Trial

This study is testing if a new type of ankle support can help people with certain ankle fractures heal just as well as the traditional cast.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ostfold Hospital Trust (other)
• Locations: 3 sites (Gjøvik and 2 other locations)
• Trial ID: NCT05412693 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of functional orthosis treatment compared to traditional cast immobilization for patients with partially unstable Weber B ankle fractures. It focuses on patients whose injuries are stable on weightbearing radiographs but unstable on gravity stress tests. The aim is to determine if functional orthosis can provide similar or better outcomes than cast immobilization, which has been the standard treatment. The study will involve patients aged 18-80 who meet specific inclusion criteria and will be conducted at multiple hospitals in Norway.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with isolated Weber B fractures that are stable on weightbearing radiographs but unstable on gravity stress tests.

Not a fit: Patients with more complex fractures, such as those involving the medial malleolus or high-energy trauma, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with ankle fractures, potentially reducing recovery time and enhancing mobility.

How similar studies have performed: While there is ongoing debate regarding the best nonoperative treatment for these injuries, no prior studies have definitively established the superiority of one method over the other, making this approach relatively novel.

Eligibility criteria

Inclusion Criteria:

* Patients:
* With isolated Weber type B fractures that are deemed stable on weightbearing radiographs (MCS injured ankle - MCS uninjured ankle \< 1 mm).
* With concomitant gravity stress test evaluated as unstable (MCS injured ankle - MCS uninjured ankle \< 1 mm)
* Presenting to one of the participating hospitals, and that are available for stability evaluation within 14 days after injury.
* 18-80 years of age
* With pre-injury walking ability without aids.

Exclusion Criteria:

* Patients:
* with fracture of the medial malleolus, pre-hospital closed fracture reduction, open fracture, fracture resulting from high-energy trauma or multi-trauma or pathologic fracture.
* with fracture of the posterior malleolus involving 25% or more of the joint surface or with a step of the intraarticular surface. (non-displaced fractures smaller than 25% can be included)
* with neuropathies and generalized joint disease such as Rheumatoid Arthritis.
* that are assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
* with previous history of ipsilateral ankle fracture.
* with previous history of ipsilateral major ankle-/foot surgery.
* who live outside one of the participating hospitals catchment areas (not available for follow-up).

Where this trial is running

Gjøvik and 2 other locations

• Sykehuset Innlandet, Gjøvik — Gjøvik, Norway (RECRUITING)
• Ålesund Hospital — Ålesund, Norway (RECRUITING)
• Østfold Hospital Trust — Sarpsborg, Østfold, Norway (RECRUITING)

Study contacts

• Study coordinator: Martin Gregersen

Conditions: Ankle Fractures, Weber B, SER4a