Distal Radius Fracture
Conditions
Brief summary
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
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.
Interventions
PROCEDUREVolar plate
Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick disabilities of the arm, shoulder and hand; Quick-DASH | 1 year | Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient rated wrist evaluation (PRWE) | 3, 6 and 12 months; 2 and 5 years | PRWE, Questionnaire |
| Grip strength | 3, 6 and 12 months; 2 and 5 years | score |
| Range of motion | 3, 6 and 12 months; 2 and 5 years | score |
| Over all satisfaction | 6 weeks; 3, 6 and 12 months; 2 and 5 years | Over all satisfaction with hand function, numeric scale 0-10 |
| Quick DASH | 3 and 6 months; 2 and 5 years | Questionnaire |
| X-ray, wrist | 6 weeks; 3 and 12 months; 2 and 5 years | Radial shortening, dorsal tilt, intraarticular step-off |
| EQ-5d (EuroQol) | 6 weeks; 3, 6 and 12 months; 2 and 5 years | Questionnaire |
| Registration of need for assistance in daily life | 6 weeks; 3, 6 and 12 months; 2 and 5 years | Registration of need for assistance in daily life to register costs generated |
| Complications | 6 weeks; 3, 6 and 12 months; 2 and 5 years | Registration of complications |
Countries
Norway
Outcome results
None listed