Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture

Quality of Life Clinical Trial

— HE-VOCAL  

Official title:

Is it Cost-effective With Volar Plating Surgery Compared to Non-operative Treatment for Distal Radius Fracture in the Elderly?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06067074
• Other study ID #: study2
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: November 4, 2024

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: November 4, 2024
• Est. primary completion date: November 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Cost-Benefit Analysis
• Fractures, Bone
• Health Care Utilization
• Postoperative Complications
• Quality of Life
• Radius Fractures
• Wrist Fracture
• Wrist Fractures
• Wrist Injuries

Intervention

Procedure:
• Volar Locking Plate
Surgery
• Plaster Cast
Non-operative treatment with a plaster cast

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division ot Ortopeadics	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Cost-Effectiveness Ratio (ICER) at 1 year.	difference in cost divided by difference in quality of life	1 year
Secondary	Absolute cost difference	difference in cost between treatments	1 and 3 years
Secondary	ICER at 3 years	difference in cost divided by difference in quality of life	3 years