Ankle Fracture, Bimalleolar Clinical Trial
Official title:
Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.
| Status | Recruiting |
| Enrollment | 29 |
| Est. completion date | December 31, 2032 |
| Est. primary completion date | December 31, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Østfold Hospital Trust | Sarpsborg | Østfold |
| Lead Sponsor | Collaborator |
|---|---|
| Ostfold Hospital Trust |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Olerud Molander Score (OMAS) to measure a change over time | Condition specific, patient reported measure of ankle-fracture symptoms | 6 week, 12 weeks, 1year, 2 years | |
| Secondary | Manchester-Oxford Foot Questionnaire (MOxFQ) | Patients reported outcomes | 6 week, 12 weeks, 1year, 2 years | |
| Secondary | Range of Motion measured by a goniometer (ad modum Lindsjo) | dorsiflexion and plantarflexion | 6 week, 12 weeks, 1year, 2 years | |
| Secondary | Numeric Rating Scale (NRS) | Ankle pain in rest, at night and in daily activities, a 11-point numeric scale ranging from 0-10 | 6 week, 12 weeks, 1year, 2 years | |
| Secondary | Euroqol questionnaire (EQ- 5D) | Health related quality of life | 6 week, 12 weeks, 1year, 2 years | |
| Secondary | Registrations of complications/adverse events | Registration of loss of congruence, delayed union, non-union, thromboembolic events | 0-2 years | |
| Secondary | Posttraumatic osteoarthritis (OA) | CT-scan (Kellgren-Lawrence classification) | 2 years and 5 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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