Clinical Trials in Norway / NCT05765929
Recruiting
Not applicable
Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
NCT05765929 · tracked via the Priya Life Science Norway tracker
Condition(s) studied
Ankle Fracture, BimalleolarAnkle Fracture, Trimalleolar
Investigational drug(s) / intervention(s)
Non-operative treatment
Non-operative treatment: Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated
Study summary
The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.
Eligibility
Inclusion Criteria:
* -With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs.
* With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6)
* With fractures in the distal 1/3 of fibula (not-Maisonneuve)
* Enabling stability evaluation within 14 days after injury
* 18-75 years of age
* with pre-injury walking ability without aids
Exclusion Criteria:
* \- With primary unstable ankle fractures, \> 7mm medial clear space on primary radiographs
* With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
* With type A medial malleolus avulsion fractures \< 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
* With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
* With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
* With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
* That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders)
* With previous history ipsilateral ankle fracture
* With previous history ipsilateral major ankle-/foot surgery
* Who live outside the hospital catchment areas not available to follow up
* With insufficient Norwegian or English language skills
* Non-compliant
Primary outcome measure(s)
- Olerud Molander Score (OMAS) to measure a change over time — 6 week, 12 weeks, 1year, 2 years
Condition specific, patient reported measure of ankle-fracture symptoms
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Østfold Hospital Trust | Sarpsborg | Østfold fylke | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05765929 on ClinicalTrials.gov ↗ ← All trials in Norway