Clinical trial NCT02336035: Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quick disabilities of the arm, shoulder and hand; Quick-DASH
timeFrame: 1 year
Secondary outcomes:
measure: Quick DASH
timeFrame: 3 and 6 months; 2 and 5 years
measure: Patient rated wrist evaluation (PRWE)
timeFrame: 3, 6 and 12 months; 2 and 5 years
measure: Grip strength
timeFrame: 3, 6 and 12 months; 2 and 5 years
measure: Range of motion
timeFrame: 3, 6 and 12 months; 2 and 5 years
measure: Over all satisfaction
timeFrame: 6 weeks; 3, 6 and 12 months; 2 and 5 years
measure: Complications
timeFrame: 6 weeks; 3, 6 and 12 months; 2 and 5 years
measure: X-ray, wrist
timeFrame: 6 weeks; 3 and 12 months; 2 and 5 years
measure: EQ-5d (EuroQol)
timeFrame: 6 weeks; 3, 6 and 12 months; 2 and 5 years
measure: Registration of need for assistance in daily life
timeFrame: 6 weeks; 3, 6 and 12 months; 2 and 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital
Study officials:
affiliation: University of Oslo
name: Jan Erik Madsen, Professor
role: STUDY_CHAIR
References: