Ireland
--:--IST
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
Phase
Not applicable
Started
2023-02-28
Last updated
2023-08-08

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
Østfold Hospital Trust Sarpsborg Østfold fylke Recruiting
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