Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation
Primary Purpose
Early Mobilization, Elbow Stiffnes, Elbow Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental early mobilisation
Aktive comparator standrad treatmnet
Sponsored by
About this trial
This is an interventional treatment trial for Early Mobilization focused on measuring Upper extremity function, Elbow stiffnes, Early mobilization
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early mobilisation
Standard treatment
Arm Description
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.
Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment.
Outcomes
Primary Outcome Measures
Oxford elbow score (OES 0-48 Points)
Evaluating pain, elbowfunction and psychological status
Secondary Outcome Measures
upper extremity activity scale (0-8)
Activity level Before and after injury
Range of motion
elbow range of motion measured with goniometer
Heterotopic ossification
Number of patients with heterotopic ossification verfified by X ray
Re-operation
Number of patients with stiff elbow who need re-operation
Patient Global impression of change
Patient satisfaction
Full Information
NCT ID
NCT04648488
First Posted
October 26, 2020
Last Updated
November 23, 2020
Sponsor
Region Östergötland
Collaborators
Kalmar County Council, Jönköping county council
1. Study Identification
Unique Protocol Identification Number
NCT04648488
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Östergötland
Collaborators
Kalmar County Council, Jönköping county council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Mobilization, Elbow Stiffnes, Elbow Fracture
Keywords
Upper extremity function, Elbow stiffnes, Early mobilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Clinical trail
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early mobilisation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment.
Intervention Type
Other
Intervention Name(s)
Experimental early mobilisation
Intervention Description
early activ assisted exercises treatment
Intervention Type
Other
Intervention Name(s)
Aktive comparator standrad treatmnet
Intervention Description
standard treatment with a plaster 3 weeks and then active assisted exercises
Primary Outcome Measure Information:
Title
Oxford elbow score (OES 0-48 Points)
Description
Evaluating pain, elbowfunction and psychological status
Time Frame
12 month follow up
Secondary Outcome Measure Information:
Title
upper extremity activity scale (0-8)
Description
Activity level Before and after injury
Time Frame
12 month follow up
Title
Range of motion
Description
elbow range of motion measured with goniometer
Time Frame
12 month follow up
Title
Heterotopic ossification
Description
Number of patients with heterotopic ossification verfified by X ray
Time Frame
3 month follow up
Title
Re-operation
Description
Number of patients with stiff elbow who need re-operation
Time Frame
in between 3 and 12 month follow up
Title
Patient Global impression of change
Description
Patient satisfaction
Time Frame
at three and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Holmgren, PhD
Phone
0046733584351
Email
teresa.holmgren@regionostergotland.se
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Björnsson Hallgren, PhD
Phone
0046709473276
Email
hanna.bjornssonhallgren@regionostergotland.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation
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