Early MobilizationNCT04648488
Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation
A study testing Experimental early mobilisation and Aktive comparator standrad treatmnet in people with Early Mobilization and Elbow Stiffnes, run by Region Östergötland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Mobilization, Elbow Stiffnes, Elbow Fracture
- What is being tested?
- Experimental early mobilisation and Aktive comparator standrad treatmnet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation - a Randomised Clinical Trial
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).
Read the 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.
- Conditions
- Early Mobilization, Elbow Stiffnes, Elbow Fracture
- Being tested
- Experimental early mobilisation, Aktive comparator standrad treatmnet
- Keywords
- Upper extremity function, Elbow stiffnes, Early mobilization
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental early mobilisationOther
early activ assisted exercises treatment
Aktive comparator standrad treatmnetOther
standard treatment with a plaster 3 weeks and then active assisted exercises
| Study group | Role | What they receive |
|---|---|---|
| Early mobilisation | Experimental | 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. Receives: Other: Experimental early mobilisation |
| Standard treatment | Active comparator | Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment. Receives: Other: Aktive comparator standrad treatmnet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford elbow score (OES 0-48 Points)
Evaluating pain, elbowfunction and psychological status
Measured: 12 month follow up
Secondary outcomes (5)
upper extremity activity scale (0-8)
Activity level Before and after injury
Measured: 12 month follow up
Range of motion
elbow range of motion measured with goniometer
Measured: 12 month follow up
Heterotopic ossification
Number of patients with heterotopic ossification verfified by X ray
Measured: 3 month follow up
Re-operation
Number of patients with stiff elbow who need re-operation
Measured: in between 3 and 12 month follow up
Patient Global impression of change
Patient satisfaction
Measured: at three and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early MobilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Clinical trail
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Collaborators
- Region Kalmar County, Jönköping county council
- Responsible party
- Principal investigator, Teresa Holmgren, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648488
- Sponsor's protocol ID
- 202004709
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation - a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04648488
- Acronym / sponsor ID
- 202004709
- Conditions
- Early Mobilization, Elbow Stiffnes, Elbow Fracture
- Keywords
- Upper extremity function, Elbow stiffnes, Early mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Collaborators
- Region Kalmar County, Jönköping county council
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Clinical trail
| Arm | Type | Receives |
|---|---|---|
| Early mobilisation | Experimental | Other: Experimental early mobilisationPatients 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 comparator | Other: Aktive comparator standrad treatmnetPatients will have a plaster 3 weeks after surgery and after that start with exercise treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental early mobilisationearly activ assisted exercises treatment | Other | Early mobilisation |
| Aktive comparator standrad treatmnetstandard treatment with a plaster 3 weeks and then active assisted exercises | Other | Standard treatment |
Primary outcome
Oxford elbow score (OES 0-48 Points)
Time frame: 12 month follow up
Evaluating pain, elbowfunction and psychological status
5 secondary outcomes
upper extremity activity scale (0-8)
Time frame: 12 month follow up
Range of motion
Time frame: 12 month follow up
Heterotopic ossification
Time frame: 3 month follow up
Re-operation
Time frame: in between 3 and 12 month follow up
Patient Global impression of change
Time frame: at three and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental early mobilisation and Aktive comparator standrad treatmnet in people with Early Mobilization and Elbow Stiffnes, run by Region Östergötland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Holmgren, PhD (0046733584351, teresa.holmgren@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford elbow score (OES 0-48 Points) (time frame: 12 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.