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

Distal Radius Fracture Clinical Trial

— DROC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02336035
• Other study ID #: 2014 3830 RCT radius 65
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2022
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick disabilities of the arm, shoulder and hand; Quick-DASH	Questionnaire	1 year
Secondary	Quick DASH	Questionnaire	3 and 6 months; 2 and 5 years
Secondary	Patient rated wrist evaluation (PRWE)	PRWE, Questionnaire	3, 6 and 12 months; 2 and 5 years
Secondary	Grip strength	score	3, 6 and 12 months; 2 and 5 years
Secondary	Range of motion	score	3, 6 and 12 months; 2 and 5 years
Secondary	Over all satisfaction	Over all satisfaction with hand function, numeric scale 0-10	6 weeks; 3, 6 and 12 months; 2 and 5 years
Secondary	Complications	Registration of complications	6 weeks; 3, 6 and 12 months; 2 and 5 years
Secondary	X-ray, wrist	Radial shortening, dorsal tilt, intraarticular step-off	6 weeks; 3 and 12 months; 2 and 5 years
Secondary	EQ-5d (EuroQol)	Questionnaire	6 weeks; 3, 6 and 12 months; 2 and 5 years
Secondary	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