Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

Study Overview
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Brief Summary
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The purpose with the study is to evalute if early mobilsation after surgery in patients vid elbow frakture-dislocation may lead to better armfunction and reduce common complications as stiffnes in the elbow. After surgery patients will be randomised to either early mobilisation (exercise treatment 3 Days after surgery) or ordinary treatment (plaster and exercise treatment 3 weeks after surgery).

Detailed Description
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In patients with elbow fracture in combinations with dislocation, surgery is often indicated. After surgery the ordinary standard praxis treatment is immobilisation in a plaster for 3 weeks. One common complication is stiff elbow. Stiffness in the elbow may be due to heterotopic ossification which is the abnormal growth of bone in the non-skeletal tissues including muscles or tendons. There is a prospective study that have reported positive results with early mobilisation starting two days after surgery in these patients. However, randomised clinical trials are missing. Therefore our aim was to investigate if early mobilisation may increase elbow function (increased range of motion and decreased pain) and also reduce comlications as stiff elbow compared to ordinary treatment in these patients. All patients operated with elbow fracture-dislocation at the University hospital in Linköping were asked if the wanted to participate in the study. They had thourough written and oral information about the study. If they agree to participate written informed consent was collected. After surgery patients were randomised to either early mobilisation or to ordinary treatment (standard praxis). At baseline before surgery or directly after patients filled in some background vatiables such as gender, age social status medical treatment etc They also filled in some self-adminstrated outcome measure in purpuse to evalute upper extremity function and activity and health related quality of Life. Follow ups with X ray and upper extremity function and activity were at 3 weeks 3 and 12 months with an independent observer. In beteween these follow ups patient followed the treatment regime (ordinary or early exrecise treatment) and had support from a physiotherapist.

Official Title
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Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation - a Randomised Clinical Trial

Conditions
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Early Mobilization, Elbow Stiffnes, Elbow Fracture

Intervention / Treatment
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* Other: Experimental early mobilisation
* Other: Aktive comparator standrad treatmnet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years with elbow fracture-dislocation being operated on. - Exclusion Criteria: ongoing cancer and earlier radiation therapy in the study arm neurological disease cervcialgia or disc herniation in the neck associated nerv or blodvessel injury dementia

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Randomised Clinical trail
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early mobilisation<br>Patients will start unloaded exercise treatment 3 days after surgery. They will remove the plaster 5 times every day to perform range of motion exercises. | Other: Experimental early mobilisation<br>* early activ assisted exercises treatment<br>|
| Active Comparator: Standard treatment<br>Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment. | Other: Aktive comparator standrad treatmnet<br>* standard treatment with a plaster 3 weeks and then active assisted exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford elbow score (OES 0-48 Points) | Evaluating pain, elbowfunction and psychological status | 12 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| upper extremity activity scale (0-8) | Activity level Before and after injury | 12 month follow up | 
| Range of motion | elbow range of motion measured with goniometer | 12 month follow up | 
| Heterotopic ossification | Number of patients with heterotopic ossification verfified by X ray | 3 month follow up | 
| Re-operation | Number of patients with stiff elbow who need re-operation | in between 3 and 12 month follow up | 
| Patient Global impression of change | Patient satisfaction | at three and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper extremity function, Elbow stiffnes, Early mobilization