Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures

Study Overview
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Brief Summary
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The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.

Official Title
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Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures

Conditions
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Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar

Intervention / Treatment
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* Other: Non-operative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-operative treatment<br>Non-operative treatment based on weightbearing radiographs | Other: Non-operative treatment<br>* Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manchester-Oxford Foot Questionnaire (MOxFQ) | Patients reported outcomes | 6 week, 12 weeks, 1year, 2 years | 
| Range of Motion measured by a goniometer (ad modum Lindsjo) | dorsiflexion and plantarflexion | 6 week, 12 weeks, 1year, 2 years | 
| 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 | 
| Euroqol questionnaire (EQ- 5D) | Health related quality of life | 6 week, 12 weeks, 1year, 2 years | 
| Registrations of complications/adverse events | Registration of loss of congruence, delayed union, non-union, thromboembolic events | 0-2 years | 
| Posttraumatic osteoarthritis (OA) | CT-scan (Kellgren-Lawrence classification) | 2 years and 5 years |