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

Unstable Distal Radius Fractures in Patients Over 65 Years. Conservative Treatment With Cast Immobilization Versus Volar Locking Plate. A Prospective Randomized Controlled Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Volar plate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0586
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Procedure: Volar plate; Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate; Other Names: Volar locking plate; VLP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick disabilities of the arm, shoulder and hand; Quick-DASH	Questionnaire	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick DASH	Questionnaire	3 and 6 months; 2 and 5 years
Patient rated wrist evaluation (PRWE)	PRWE, Questionnaire	3, 6 and 12 months; 2 and 5 years
Grip strength	score	3, 6 and 12 months; 2 and 5 years
Range of motion	score	3, 6 and 12 months; 2 and 5 years
Over all satisfaction	Over all satisfaction with hand function, numeric scale 0-10	6 weeks; 3, 6 and 12 months; 2 and 5 years
Complications	Registration of complications	6 weeks; 3, 6 and 12 months; 2 and 5 years
X-ray, wrist	Radial shortening, dorsal tilt, intraarticular step-off	6 weeks; 3 and 12 months; 2 and 5 years
EQ-5d (EuroQol)	Questionnaire	6 weeks; 3, 6 and 12 months; 2 and 5 years
Registration of need for assistance in daily life	Registration of need for assistance in daily life to register costs generated	6 weeks; 3, 6 and 12 months; 2 and 5 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Chair: Jan Erik Madsen, Professor, University of Oslo

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2018
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: January 7, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 2014 3830 RCT radius 65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED