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

NCT02336035 | Unknown

• 1 other identifier: 2014 3830 RCT radius 65
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Quick disabilities of the arm, shoulder and hand; Quick-DASH

  Questionnaire

  1 year

Secondary Outcomes (9)

• Quick DASH

  3 and 6 months; 2 and 5 years

• Patient rated wrist evaluation (PRWE)

  3, 6 and 12 months; 2 and 5 years

• Grip strength

  3, 6 and 12 months; 2 and 5 years

• Range of motion

  3, 6 and 12 months; 2 and 5 years

• Over all satisfaction

  6 weeks; 3, 6 and 12 months; 2 and 5 years

Study Arms (2)

Cast immobilization

NO INTERVENTION

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

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

Interventions

Volar plate PROCEDURE

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

Also known as: Volar locking plate, VLP

Operation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• Ability to reconstruct the articular surface with a volar locking plate

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University hospital

Oslo, 0586, Norway

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Jan Erik Madsen, Professor

  University of Oslo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 12, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2022
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

NO (1)