Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?
- Conditions
- Distal Radius Fracture
- Interventions
- Procedure: Volar plate
- Registration Number
- NCT02336035
- Lead Sponsor
- Oslo University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Operation Volar plate 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.
- Primary Outcome Measures
Name Time Method Quick disabilities of the arm, shoulder and hand; Quick-DASH 1 year Questionnaire
- Secondary Outcome Measures
Name Time Method Grip strength 3, 6 and 12 months; 2 and 5 years score
Complications 6 weeks; 3, 6 and 12 months; 2 and 5 years Registration of complications
Patient rated wrist evaluation (PRWE) 3, 6 and 12 months; 2 and 5 years PRWE, Questionnaire
X-ray, wrist 6 weeks; 3 and 12 months; 2 and 5 years Radial shortening, dorsal tilt, intraarticular step-off
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
Range of motion 3, 6 and 12 months; 2 and 5 years score
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
EQ-5d (EuroQol) 6 weeks; 3, 6 and 12 months; 2 and 5 years Questionnaire
Trial Locations
- Locations (1)
Oslo University hospital
🇳🇴Oslo, Norway