Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation - a Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Region Östergötland
- Enrollment
- 60
- Primary Endpoint
- Oxford elbow score (OES 0-48 Points)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Early mobilisation
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.
Intervention: Experimental early mobilisation (Other)
Standard treatment
Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment.
Intervention: Aktive comparator standrad treatmnet (Other)
Outcomes
Primary Outcomes
Oxford elbow score (OES 0-48 Points)
Time Frame: 12 month follow up
Evaluating pain, elbowfunction and psychological status
Secondary Outcomes
- Patient Global impression of change(at three and 12 months)
- Re-operation(in between 3 and 12 month follow up)
- Range of motion(12 month follow up)
- Heterotopic ossification(3 month follow up)
- upper extremity activity scale (0-8)(12 month follow up)
Investigators
Teresa Holmgren
PhD Registered physiotherapist
Region Östergötland