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Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.
The investigators want to investigate if there is a difference between operative treatment with volar locking plates and cast immobilization in patient above 65 years with unstable distal radius fractures AO/OTA type A and C . Eligible patients that meets the radiological criteria (see inclusion criteria) will be randomized to cast immobilization or operation with volar locking plate.
The investigators are planning a non-inferiority design.
The current study will test the following null hypothesis:
In patients over 65 years of age with unstable distal radius fractures AO/OTA type A and C,volar locking plates are superior to cast immobilization by more than 8 points, as evaluated by quick-DASH at 12 months follow-up.
The investigators will perform a cost-effectiveness analysis comparing QALYs (Quality-adjusted life years) and costs with the two interventions the first year of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cast immobilization | No Intervention | Cast immobilization for 5 weeks from primary injury/reduction. Thereafter active exercise within the range of pain. Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years. | |
| Operation | Experimental | Operation with a volar plate. Cast immobilization for 2 weeks after operation, thereafter active motion without weight for 4 weeks. 6 weeks after operation the patients are allowed active exercise within the range of pain. Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volar plate | Procedure | Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quick disabilities of the arm, shoulder and hand; Quick-DASH | Questionnaire | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quick DASH | Questionnaire | 3 and 6 months; 2 and 5 years |
| Patient rated wrist evaluation (PRWE) | PRWE, Questionnaire | 3, 6 and 12 months; 2 and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Erik Madsen, Professor | University of Oslo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University hospital | Oslo | 0586 | Norway |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Grip strength | score | 3, 6 and 12 months; 2 and 5 years |
| Range of motion | score | 3, 6 and 12 months; 2 and 5 years |
| Over all satisfaction | Over all satisfaction with hand function, numeric scale 0-10 | 6 weeks; 3, 6 and 12 months; 2 and 5 years |
| Complications | Registration of complications | 6 weeks; 3, 6 and 12 months; 2 and 5 years |
| X-ray, wrist | Radial shortening, dorsal tilt, intraarticular step-off | 6 weeks; 3 and 12 months; 2 and 5 years |
| EQ-5d (EuroQol) | Questionnaire | 6 weeks; 3, 6 and 12 months; 2 and 5 years |
| Registration of need for assistance in daily life | Registration of need for assistance in daily life to register costs generated | 6 weeks; 3, 6 and 12 months; 2 and 5 years |