Clinical trial NCT04648488: Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation
Official title: Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation - a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Mobilization
Elbow Stiffnes
Elbow Fracture
Keywords: Upper extremity function
Elbow stiffnes
Early mobilization
Lead sponsor: Region Östergötland
Sponsor class: OTHER
Collaborators: name: Kalmar County Council
name: Jönköping county council
First posted: 2020-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Clinical trail
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: Patients over 18 years with elbow fracture-dislocation being operated on.

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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

Primary outcomes:
measure: Oxford elbow score (OES 0-48 Points)
timeFrame: 12 month follow up
Secondary outcomes:
measure: upper extremity activity scale (0-8)
timeFrame: 12 month follow up
measure: Range of motion
timeFrame: 12 month follow up
measure: Heterotopic ossification
timeFrame: 3 month follow up
measure: Re-operation
timeFrame: in between 3 and 12 month follow up
measure: Patient Global impression of change
timeFrame: at three and 12 months
Other outcomes:
Locations:
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