NCT06343467

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

Completed NA Results posted Last updated 28 August 2024

What this trial tests

NA trial testing Generic Volar Locking Plate in Distal Radius Fractures in 101 participants. Completed in 30 April 2023.

Timeline

1 November 2022

Primary endpoint
30 April 2023

30 April 2023

Quick facts

Lead sponsor	HealthPartners Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	101
Start date	1 November 2022
Primary completion	30 April 2023
Estimated completion	30 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Generic Volar Locking Plate
• Conventional Volar Locking Plate

Conditions studied

• Distal Radius Fractures — all drugs for Distal Radius Fractures →

Sponsor

HealthPartners Institute

Who can join

18 and older, any sex, with Distal Radius Fractures. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

90-day Reoperation Rate Primary · Within 90 days postoperatively

Reoperation for any reason postoperatively within 90 days after the date of surgery.

Group	Value	95% CI
Generic Implant	0
Conventional Implant	0

90-day Readmission Rate Primary · Within 90 days postoperatively

Readmission to the hospital for any reason postoperatively within 90 days after the date of surgery.

Group	Value	95% CI
Generic Implant	0
Conventional Implant	0

90-day Mortality Rate Primary · Within 90 days postoperatively

Patient death at any point within 90 days after the date of surgery.

Group	Value	95% CI
Generic Implant	0
Conventional Implant	0

Implant Cost Secondary · Day of Surgery

The total cost of implants used in the procedure, including screws, pegs, volar locking plates, and disposable implants.

Group	Value	95% CI
Generic Implant	702.38	± 47.83
Conventional Implant	1348.61	± 100.77

Tourniquet Time Secondary · From tourniquet inflation to deflation during the procedure.

The total time in minutes from tourniquet inflation to deflation for a surgical case.

Group	Value	95% CI
Generic Implant	49.05	± 19.2
Conventional Implant	45.06	± 12.84

Estimated Blood Loss Secondary · Day of Surgery

Estimated blood loss for the surgical case as reported by the surgeon in milliliters.

Group	Value	95% CI
Generic Implant	13.3	± 10.2
Conventional Implant	13.2	± 6.8

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Generic Volar Locking Plate Use in Distal Radius Fractures: A Prospective Randomized Study to Evaluate Clinical Outcomes and Cost Reduction.
   Doxey SA, Kleinsmith RM, Qian LJ, Husband JB, et al · · 2026 · PMID 39506267 · DOI 10.1177/15589447241293168