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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Postoperative Complications; Wrist Injuries; Radius Fractures; Aged; Health Care Utilization; Cost-Benefit Analysis; Wrist Fracture
• Intervention / Treatment: Procedure: Volar Locking Plate; Procedure: Plaster Cast

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division ot Ortopeadics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volar Locking Plate; Surgery with a Volar Locking Plate due to displaced distal radius fracture	Procedure: Volar Locking Plate; Surgery
Experimental: Non-operative treatment group; Patients allocated to non-operative treatment received a plaster cast for 4-5 weeks.	Procedure: Plaster Cast; Non-operative treatment with a plaster cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental Cost-Effectiveness Ratio (ICER) at 1 year.	difference in cost divided by difference in quality of life	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute cost difference	difference in cost between treatments	1 and 3 years
ICER at 3 years	difference in cost divided by difference in quality of life	3 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Olof Sköldenberg, professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Estimated): November 4, 2024
• Study Completion (Estimated): November 4, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Postoperative Complications; Wrist Injuries; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: study2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No