search
Back to results

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

Primary Purpose

Radius Fractures, Aged, Cost-Benefit Analysis

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Volar Locking Plate
Plaster Cast
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Radius Fractures

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Volar Locking Plate

Non-operative treatment group

Arm Description

Surgery with a Volar Locking Plate due to displaced distal radius fracture

Patients allocated to non-operative treatment received a plaster cast for 4-5 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Absolute cost difference
difference in cost between treatments
ICER at 3 years
difference in cost divided by difference in quality of life

Full Information

First Posted
May 12, 2022
Last Updated
October 2, 2023
Sponsor
Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT06067074
Brief Title
Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture
Acronym
HE-VOCAL
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
November 4, 2024 (Anticipated)
Study Completion Date
November 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fractures, Aged, Cost-Benefit Analysis, Wrist Fracture, Quality of Life, Wrist Injuries, Postoperative Complications, Health Care Utilization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volar Locking Plate
Arm Type
Experimental
Arm Description
Surgery with a Volar Locking Plate due to displaced distal radius fracture
Arm Title
Non-operative treatment group
Arm Type
Experimental
Arm Description
Patients allocated to non-operative treatment received a plaster cast for 4-5 weeks.
Intervention Type
Procedure
Intervention Name(s)
Volar Locking Plate
Intervention Description
Surgery
Intervention Type
Procedure
Intervention Name(s)
Plaster Cast
Intervention Description
Non-operative treatment with a plaster cast
Primary Outcome Measure Information:
Title
Incremental Cost-Effectiveness Ratio (ICER) at 1 year.
Description
difference in cost divided by difference in quality of life
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Absolute cost difference
Description
difference in cost between treatments
Time Frame
1 and 3 years
Title
ICER at 3 years
Description
difference in cost divided by difference in quality of life
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olof Sköldenberg, professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division ot Ortopeadics
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs