Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Region Kalmar County | OTHER |
| Jönköping county council | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard treatment | Active Comparator | Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental early mobilisation | Other | early activ assisted exercises treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford elbow score (OES 0-48 Points) | Evaluating pain, elbowfunction and psychological status | 12 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| upper extremity activity scale (0-8) | Activity level Before and after injury | 12 month follow up |
| Range of motion | elbow range of motion measured with goniometer |
Not provided
Inclusion Criteria: Patients over 18 years with elbow fracture-dislocation being operated on.
-
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Holmgren, PhD | Contact | 0046733584351 | teresa.holmgren@regionostergotland.se | |
| Hanna Björnsson Hallgren, PhD | Contact | 0046709473276 | hanna.bjornssonhallgren@regionostergotland.se |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2020 | Nov 23, 2020 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
Randomised Clinical trail
Not provided
Not provided
Not provided
| Aktive comparator standrad treatmnet |
| Other |
standard treatment with a plaster 3 weeks and then active assisted exercises |
|
| 12 month follow up |
| Heterotopic ossification | Number of patients with heterotopic ossification verfified by X ray | 3 month follow up |
| Re-operation | Number of patients with stiff elbow who need re-operation | in between 3 and 12 month follow up |
| Patient Global impression of change | Patient satisfaction | at three and 12 months |