MedTrace Logo

Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost?

NCT06343467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2024-08-28

Study results available
· View outcomes & findings →

Summary

Across orthopedics, the investigators will be using the generic volar locking plates for patients undergoing open reduction and internal fixation (ORIF) of the distal radius using a block schedule, meaning one month we the generic implants and one month we use conventional implants from the surgeon's brand of choice. At the end of each month the health system will switch which type of implants (generic vs. conventional) they will use at their facilities. From a quality perspective each patient will be monitored both short and long term for complication and reoperation. This will be done through chart review.

Conditions

  • Distal Radius Fractures

Interventions

DEVICE

Generic Volar Locking Plate

Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.

DEVICE

Conventional Volar Locking Plate

Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm.

Sponsors & Collaborators

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Brian Cunningham, MD · HealthPartners Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06343467 on ClinicalTrials.gov