Post Operative Quality of Life and Pain in Ankle Fractures: Cast Versus Functional Treatment

Study Overview
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Brief Summary
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Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. Both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. Insight into the quality of life and the level of pain is necessary to determine if these treatments can be related to higher patient satisfaction and earlier resumption of daily activities and work. Objective: The aim of this study is to examine two postoperative treatments for surgically corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short term plaster cast fixation. The focus of this study is on quality of life, pain and the use of pain medication, and resumption of work and daily activities. Main study parameters/endpoints: Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain disability index), complications

Official Title
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Post Operative Evaluation of Quality of Life and Pain in Ankle Fractures: Cast Immobilisation Versus Functional Treatment

Conditions
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Ankle Fractures

Intervention / Treatment
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* Other: Functional mobilisation
* Other: Short term plaster cast fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 at the time of surgery Ankle fractures needing operative correction Weber type B or C, Lauge Hansen type supination-adduction, supination-external rotation and pronation-external rotation Closed fractures Postoperative stable for exercise Operated at the University Medical Centre St Radboud, Nijmegen or Alysis Zorggroep, Rijnstate Hospital, Arnhem Exclusion Criteria: Open fractures Fractures with complete dislocation of the ankle joint Body Mass Index > 30 Previous ankle fracture on the affected side Concomitant traumatic injuries reducing the ability for postoperative mobilization Pre-existent use of pain medication, medication affecting fracture- and wound healing Postoperative unstable for exercise Co-morbidity: pain syndromes, Fontaine IIB, III and IV, symptomatic venous insufficiency, auto-immune disorders, rheumatic arthritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Functional mobilisation<br> | Other: Functional mobilisation<br>* functional mobilisation<br>|
| Experimental: plaster cast fixation<br> | Other: Short term plaster cast fixation<br>* 2 weeks cast immobilisation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Visual Analog Pain Scale | 6 weeks | 
| Pain medication used | amount of pain medication used | 6 weeks |