Trials / Unknown
UnknownNCT04648488
Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation
Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation - a Randomised Clinical Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Region Östergötland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Experimental early mobilisation | early activ assisted exercises treatment |
| OTHER | Aktive comparator standrad treatmnet | standard treatment with a plaster 3 weeks and then active assisted exercises |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2023-01-01
- Completion
- 2023-01-01
- First posted
- 2020-12-01
- Last updated
- 2020-12-01
Source: ClinicalTrials.gov record NCT04648488. Inclusion in this directory is not an endorsement.