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

University of Oslo (UIO)

Status: Unknown

Conditions: Distal Radius Fracture

Treatments: Procedure: Volar plate

Study type: Interventional

Funder types: Other

Identifiers

NCT02336035

2014 3830 RCT radius 65

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Cast immobilization

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Procedure: Volar plate