Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation
1 other identifier
interventional
60
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
December 1, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedDecember 1, 2020
November 1, 2020
2 years
October 26, 2020
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxford elbow score (OES 0-48 Points)
Evaluating pain, elbowfunction and psychological status
12 month follow up
Secondary Outcomes (5)
upper extremity activity scale (0-8)
12 month follow up
Range of motion
12 month follow up
Heterotopic ossification
3 month follow up
Re-operation
in between 3 and 12 month follow up
Patient Global impression of change
at three and 12 months
Study Arms (2)
Early mobilisation
EXPERIMENTALPatients will start unloaded exercise treatment 3 days after surgery. They will remove the plaster 5 times every day to perform range of motion exercises.
Standard treatment
ACTIVE COMPARATORPatients will have a plaster 3 weeks after surgery and after that start with exercise treatment.
Interventions
standard treatment with a plaster 3 weeks and then active assisted exercises
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Östergötlandlead
- Kalmar County Councilcollaborator
- Jönköping county councilcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Registered physiotherapist
Study Record Dates
First Submitted
October 26, 2020
First Posted
December 1, 2020
Study Start
January 1, 2021
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
December 1, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share