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

NCT06343467 | Completed Results FDA Device

• 1 other identifier: A17-376
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Volar Locking Plate; Generic Implants

Outcome Measures

Primary Outcomes (3)

• 90-day Reoperation Rate

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

  Within 90 days postoperatively

• 90-day Readmission Rate

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

  Within 90 days postoperatively

• 90-day Mortality Rate

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

  Within 90 days postoperatively

Secondary Outcomes (3)

• Implant Cost

  Day of Surgery

• Tourniquet Time

  From tourniquet inflation to deflation during the procedure.

• Estimated Blood Loss

  Day of Surgery

Study Arms (2)

Generic Implant

EXPERIMENTAL

Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.

Device: Generic Volar Locking Plate

Conventional Implant

ACTIVE COMPARATOR

Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.

Device: Conventional Volar Locking Plate

Interventions

Generic Volar Locking Plate DEVICE

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.

Generic Implant

Conventional Volar Locking Plate DEVICE

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

Conventional Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated distal radius fracture
• Treated surgically with a volar locking plate

You may not qualify if:

• Volar locking plate not used
• Additional fixation was used
• Polytrauma (non-isolated injury)
• Open fracture
• \<18 years old

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (7)

• Walker JA, Althausen PL. Surgeon Attitudes Regarding the Use of Generic Implants: An OTA Survey Study. J Orthop Trauma. 2016 Dec;30 Suppl 5:S27-S31. doi: 10.1097/BOT.0000000000000722.

  PMID: 27870671 BACKGROUND

• Waldrop VH, Laverty DC, Bozic KJ. Value-based Healthcare: Increasing Value by Reducing Implant-related Health Care Costs. Clin Orthop Relat Res. 2019 Feb;477(2):281-283. doi: 10.1097/01.blo.0000534683.24250.9c. No abstract available.

  PMID: 29762154 BACKGROUND

• Miner HR, Slover JD, Koenig KM. Price Transparency and Consumer Perceptions of Generic and Brand-name Implants in Orthopaedic Surgery. Arch Bone Jt Surg. 2022 Sep;10(9):791-797. doi: 10.22038/ABJS.2022.51855.2558.

  PMID: 36246025 BACKGROUND

• Mcphillamy A, Gurnea TP, Moody AE, Kurnik CG, Lu M. The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center. J Orthop Trauma. 2016 Dec;30 Suppl 5:S32-S36. doi: 10.1097/BOT.0000000000000721.

  PMID: 27870672 BACKGROUND

• Khoo KM, Kim GW, Lindvall EM, Martirosian AK. Outcomes and Cost Comparison Between Generic and Conventional Cephalomedullary Nails in the Treatment of Peritrochanteric Femur Fractures. J Am Acad Orthop Surg. 2022 Feb 1;30(3):119-124. doi: 10.5435/JAAOS-D-21-00024.

  PMID: 34715691 BACKGROUND

• Doxey SA, Huyke-Hernandez FA, Robb JL, Bohn DC, Cunningham BP. A Case Series of Surgically Treated Distal Radius Fractures: Implant Costs and Their Effect on Patient Outcomes. J Am Acad Orthop Surg Glob Res Rev. 2023 Jul 7;7(7):e23.00026. doi: 10.5435/JAAOSGlobal-D-23-00026. eCollection 2023 Jul 1.

  PMID: 37428150 BACKGROUND

• Doxey SA, Huyke-Hernandez FA, Robb JL, Bohn DC, Cunningham BP. Implant cost variation in surgically treated distal radius fractures. J Orthop. 2023 Apr 7;39:45-49. doi: 10.1016/j.jor.2023.04.003. eCollection 2023 May.

  PMID: 37125012 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Results Point of Contact

• Title: Megan Reams; Director of Orthopaedic Research
• Organization: TRIA Orthopedic Center

megan.reams@tria.com

(952) 806-5329

Study Officials

• Brian Cunningham, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients underwent the standard surgical consent, however the specific plate vendor that was used, was not specified by the physician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Surgeons alternated between using generic implants and conventional implants in their distal radius fracture patients over the course of six months.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 2, 2024
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)