Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Unstable Distal Radius Fractures in Patients Over 65 Years. Conservative Treatment With Cast Immobilization Versus Volar Locking Plate. A Prospective Randomized Controlled Trial.

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Procedure: Volar plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AO/OTA class A- and C-fractures Age > 65 years Unacceptable primary reduction or redislocation < 20 days post-injury with at least one of the following findings: dorsal angulation > 10 degrees radial shortening > 3 mm intraarticular step-off > 2 mm Ability to sign an informed consent Acute fracture, inclusion within 20 days from injury. Ability to reconstruct the articular surface with a volar locking plate Exclusion Criteria: Volar angulated fractures and AO type B Associated diseases contraindicating surgery Mental impairment, nursery home patient Earlier wrist injury Pathological fractures Open fractures (>Gustilo-Anderson I) or damaged soft tissue Drug abuse Concomitant injuries that might affect outcome Congenital anomaly of affected extremity Median nerve compression that requires acute operation Foreign language Tourists

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Cast immobilization<br>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. | |
| Experimental: Operation<br>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. | Procedure: Volar plate<br>* Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate<br>* Other names: VLP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick disabilities of the arm, shoulder and hand; Quick-DASH | Questionnaire | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |