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

NCT ID: NCT06343467

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-04-30

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.

Detailed Description

Patients will be consented to surgery per a standard surgical consent form. Six surgeons who regularly perform distal radius fracture (DRF) ORIF are included (five hand and one orthopaedic trauma fellowship-trained). Per the practice protocol, patients will either be treated with a generic plate or a brand name plate as described above. Ultimately, the decision to use a generic volar locking plate (VLP) is left up to surgeon discretion. All surgical and follow-up data will be collected. Implants used, age at time of surgery, weight, height, gender, race, ethnicity, comorbidities (diabetes, heart disease, etc.), complications including, but not limited to: readmission, reoperation, non-union, wound dehiscence, and lab tests will be collected. This will be evaluated all within 90 days following surgery. Implants will be cross referenced with the institution's data base to determine cost. All data will be collected on a secure server and be kept password protected. The primary outcome was 90-day postoperative complications (readmissions, reoperations, and mortality rates) by implant vendor type (generic vs. conventional). Secondary outcomes consisted of implant costs, estimated blood loss, and tourniquet time. An a priori power analysis was conducted to estimate the minimum sample size needed to adequately detect a difference in reoperation rates with a large effect size (Cohen's d=0.8). At a Type I error rate of 0.05, a power of 80%, and a 1:1 group allocation, the estimated sample size was 36 patients (18 generic VLPs vs. 18 conventional VLPs). Statistical significance was set to p≤0.05.

Conditions

Distal Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Generic Implant

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

Group Type: EXPERIMENTAL

Generic Volar Locking Plate

Intervention Type: 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.

Conventional Implant

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.

Group Type: ACTIVE_COMPARATOR

Conventional Volar Locking Plate

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Cunningham, MD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

Regions Hospital

Saint Paul, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27870671 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29762154 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36246025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27870672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34715691 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37428150 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37125012 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A17-376

Identifier Type: -

Identifier Source: org_study_id