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

Sponsor

Karolinska Institutet (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06067074

Collaborator

(none)

140

Enrollment

Location

Arms

32.9

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radius Fractures Aged Cost-Benefit Analysis Wrist Fracture Quality of Life Wrist Injuries Postoperative Complications Health Care Utilization	Procedure: Volar Locking Plate Procedure: Plaster Cast	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Feb 8, 2022

Anticipated Primary Completion Date :

Nov 4, 2024

Anticipated Study Completion Date :

Nov 4, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incremental Cost-Effectiveness Ratio (ICER) at 1 year. [1 year]
difference in cost divided by difference in quality of life

Secondary Outcome Measures

Absolute cost difference [1 and 3 years]
difference in cost between treatments
ICER at 3 years [3 years]
difference in cost divided by difference in quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division ot Ortopeadics	Stockholm		Sweden

Sponsors and Collaborators

Karolinska Institutet

Investigators

Principal Investigator: Olof Sköldenberg, professor, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cecilia Mellstrand Navarro, associate professor, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT06067074

Other Study ID Numbers:

study2

First Posted:

Oct 4, 2023

Last Update Posted:

Oct 4, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Postoperative Complications

Study Results

No Results Posted as of Oct 4, 2023