PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.

Study Overview
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Brief Summary
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PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.

Detailed Description
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Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.

Official Title
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Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.

Conditions
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Lateral Malleolus Fractures

Intervention / Treatment
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* Other: Splint 3 weeks
* Other: Cast 3 weeks
* Other: Cast 6 weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable Weber-B type fibula fracture ER-stress negative 16 or over years old Willingness to participate on study proved by a signature and date Walking without aid before accident Treatment started within 7 days from injury Exclusion Criteria: Prior ankle fracture or significant fracture in the area of ankle or leg Bilateral ankle fracture Pathological fracture Diabetes mellitus or an other significant periferial neuropathy municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital Patient's understanding or co-operation inadequate

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Splint 3 weeks<br>Removable ankle brace/splint | Other: Splint 3 weeks<br>* A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal.<br>|
| Active Comparator: Cast 3 weeks<br>Below-the-knee cast (glass fiber) | Other: Cast 3 weeks<br>* A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal.<br>|
| Active Comparator: Cast 6 weeks<br>Below-the-knee cast (glass fiber) | Other: Cast 6 weeks<br>* standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Olerud-Molander score | Ankle functional outcome measure | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAOS | Foot and Ankle Outcome Score | 1 year | 
| VAS | Visual Analogue Scale pain and function | 1 year | 
| RAND 36 Health item survey | Quality of life measurement | 1 year | 
| Fracture healing |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ER-stress-test negative, unimalleolar, fibula, Weber-B fractures