Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
Study Details
Study Description
Brief Summary
The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Non-operative treatment Non-operative treatment based on weightbearing radiographs |
Other: Non-operative treatment
Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated
|
Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- Manchester-Oxford Foot Questionnaire (MOxFQ) [6 week, 12 weeks, 1year, 2 years]
Patients reported outcomes
- Range of Motion measured by a goniometer (ad modum Lindsjo) [6 week, 12 weeks, 1year, 2 years]
dorsiflexion and plantarflexion
- Numeric Rating Scale (NRS) [6 week, 12 weeks, 1year, 2 years]
Ankle pain in rest, at night and in daily activities, a 11-point numeric scale ranging from 0-10
- Euroqol questionnaire (EQ- 5D) [6 week, 12 weeks, 1year, 2 years]
Health related quality of life
- Registrations of complications/adverse events [0-2 years]
Registration of loss of congruence, delayed union, non-union, thromboembolic events
- Posttraumatic osteoarthritis (OA) [2 years and 5 years]
CT-scan (Kellgren-Lawrence classification)
Eligibility Criteria
Criteria
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.
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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)
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With fractures in the distal 1/3 of fibula (not-Maisonneuve)
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Enabling stability evaluation within 14 days after injury
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18-75 years of age
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with pre-injury walking ability without aids
Exclusion Criteria:
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- With primary unstable ankle fractures, > 7mm medial clear space on primary radiographs
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With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
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With type A medial malleolus avulsion fractures < 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
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With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
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With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
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With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
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That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders)
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With previous history ipsilateral ankle fracture
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With previous history ipsilateral major ankle-/foot surgery
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Who live outside the hospital catchment areas not available to follow up
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With insufficient Norwegian or English language skills
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Non-compliant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Østfold Hospital Trust | Sarpsborg | Østfold | Norway | 1714 |
Sponsors and Collaborators
- Ostfold Hospital Trust
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 47891