Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT05412693
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05412693
Study Brief:
Protocol Section:
NCT05412693