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

NCT06067074 | Unknown

• 1 other identifier: study2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incremental Cost-Effectiveness Ratio (ICER) at 1 year.

  difference in cost divided by difference in quality of life

  1 year

Secondary Outcomes (2)

• Absolute cost difference

  1 and 3 years

• ICER at 3 years

  3 years

Study Arms (2)

Volar Locking Plate

EXPERIMENTAL

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

Procedure: Volar Locking Plate

Non-operative treatment group

EXPERIMENTAL

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

Procedure: Plaster Cast

Interventions

Volar Locking Plate PROCEDURE

Surgery

Volar Locking Plate

Plaster Cast PROCEDURE

Non-operative treatment with a plaster cast

Non-operative treatment group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patient \>70 years
• wrist radiograph \>20° dorsal tilt and/or +/-4 mm axial shortening

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

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

Stockholm, Sweden

Location

MeSH Terms

Conditions

Radius Fractures; Wrist Fractures; Wrist Injuries; Postoperative Complications; Patient Acceptance of Health Care

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Olof Sköldenberg, professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: October 4, 2023
• Study Start: February 8, 2022
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)