- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04648488
Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation
Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation - a Randomised Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Teresa Holmgren, PhD
- Phone Number: 0046733584351
- Email: teresa.holmgren@regionostergotland.se
Study Contact Backup
- Name: Hanna Björnsson Hallgren, PhD
- Phone Number: 0046709473276
- Email: hanna.bjornssonhallgren@regionostergotland.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
early activ assisted exercises treatment
|
ACTIVE_COMPARATOR: Standard treatment
Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment.
|
standard treatment with a plaster 3 weeks and then active assisted exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxford elbow score (OES 0-48 Points)
Time Frame: 12 month follow up
|
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)
Time Frame: 12 month follow up
|
Activity level Before and after injury
|
12 month follow up
|
Range of motion
Time Frame: 12 month follow up
|
elbow range of motion measured with goniometer
|
12 month follow up
|
Heterotopic ossification
Time Frame: 3 month follow up
|
Number of patients with heterotopic ossification verfified by X ray
|
3 month follow up
|
Re-operation
Time Frame: in between 3 and 12 month follow up
|
Number of patients with stiff elbow who need re-operation
|
in between 3 and 12 month follow up
|
Patient Global impression of change
Time Frame: at three and 12 months
|
Patient satisfaction
|
at three and 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202004709
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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