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

NCT ID: NCT02336035

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2022-09-30

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.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cast immobilization

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Operation

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.

Group Type: EXPERIMENTAL

Volar plate

Intervention Type: PROCEDURE

Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate

Interventions

Volar plate

Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate

Intervention Type: PROCEDURE

Other Intervention Names

Volar locking plate; VLP

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sondre Stafsne Hassellund

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Erik Madsen, Professor

Role: STUDY_CHAIR

University of Oslo

Locations

Oslo University hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

2014 3830 RCT radius 65

Identifier Type: -

Identifier Source: org_study_id