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

Oslo University Hospital100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Distal Radius Fracture

Interventions

Volar platePROCEDURE

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Oslo University hospital

Oslo, Norway

Outcomes

Primary Outcomes

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

Questionnaire

Time frame: 1 year

Secondary Outcomes

Quick DASH

Questionnaire

Time frame: 3 and 6 months; 2 and 5 years

Patient rated wrist evaluation (PRWE)

PRWE, Questionnaire

Time frame: 3, 6 and 12 months; 2 and 5 years

Grip strength

score

Time frame: 3, 6 and 12 months; 2 and 5 years

Range of motion

score

Time frame: 3, 6 and 12 months; 2 and 5 years

Over all satisfaction

Over all satisfaction with hand function, numeric scale 0-10

Time frame: 6 weeks; 3, 6 and 12 months; 2 and 5 years

Complications

Registration of complications

Time frame: 6 weeks; 3, 6 and 12 months; 2 and 5 years

X-ray, wrist

Radial shortening, dorsal tilt, intraarticular step-off

Time frame: 6 weeks; 3 and 12 months; 2 and 5 years

EQ-5d (EuroQol)

Questionnaire

Time frame: 6 weeks; 3, 6 and 12 months; 2 and 5 years

Data from ClinicalTrials.gov

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