Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture (HE-VOCAL)

Karolinska Institute

Status

Active, not recruiting

Conditions

Postoperative Complications

Wrist Injuries

Radius Fractures

Quality of Life

Cost-Benefit Analysis

Wrist Fracture

Health Care Utilization

Aged

Treatments

Procedure: Volar Locking Plate

Procedure: Plaster Cast

Study type

Interventional

Funder types

Other

Identifiers

NCT06067074

study2

Details and patient eligibility

About

A cost-utility analysis based on an earlier published RCT comparing surgery with volar locking plate to non-operative treatment for the elderly with a displaced distal radius fracture.

Full description

Study design: A cost-utility analysis of a patient population included in a previous published randomized controlled trial.

Patient population:140 patients 70 years of age or older with a displaced distal radius fracture that met the inclusion and no exclusion criteria at Danderyd Hospital or Södersjukhuset Hospital were randomized to volar locking plate or non-operative treatment with a cast.

Primary outcome: Incremental cost-effectiveness ratio (ICER) at 1 and 3 years.

Data collection: Prospectively collected clinical data is available for 4, 12, weeks, 1 and 3 years. Costs will be analysed regarding surgical equipment, inpatient stay, surgical time. Prescriptions of analgesics and antibiotics as well as inpatient and outpatient consumption over a three years period after the injury will be retrieved from the Swedish National Board of Health and Welfare.The life expectancy adjusted life years (QALYs) is calculated from prospectively collected results from EQ-5D.

Enrollment

140 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

patient >70 years
wrist radiograph >20° dorsal tilt and/or +/-4 mm axial shortening

Exclusion Criteria

Former disability of either wrist
Intra-articular fractures with a step-off of >1 mm or a gap of > 1 mm (at Sodersjukhuset Hospital)
High-energy trauma (Sodersjukhuset Hospital)
Associated ulnar fracture
Injury to ipsilateral upper extremity
Rheumatoid arthritis or other severe joint disorders
Dementia or Pfeiffer score of <5 at Sodersjukhuset Hospital and <8 at Danderyd Hospital
Drug or alcohol abuse or psychiatric disorder
Dependency in activities of daily living
Patient not a resident within the catchment area of the 2 centers
Fracture diagnosed >3 days from injury at Sodersjukhuset Hospital and >6 days at Danderyd Hospital
Patient not fit for surgery or American Society of Anesthesiologists class 4