Clinical trial NCT06067074: Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture
Official title: Is it Cost-effective With Volar Plating Surgery Compared to Non-operative Treatment for Distal Radius Fracture in the Elderly?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Radius Fractures
Aged
Cost-Benefit Analysis
Wrist Fracture
Quality of Life
Wrist Injuries
Postoperative Complications
Health Care Utilization
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 140
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallell study arms with the intervention volar locking plate and control treatment forearm cast. We investigate the difference in health cost between the two groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Incremental Cost-Effectiveness Ratio (ICER) at 1 year.
timeFrame: 1 year
Secondary outcomes:
measure: Absolute cost difference
timeFrame: 1 and 3 years
measure: ICER at 3 years
timeFrame: 3 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division ot Ortopeadics
Study officials:
affiliation: Karolinska Institutet
name: Olof Sköldenberg, professor
role: PRINCIPAL_INVESTIGATOR
References: