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

HealthPartners Institute

Status: Completed

Conditions: Distal Radius Fractures

Treatments: Device: Conventional Volar Locking Plate; Device: Generic Volar Locking Plate

Study type: Interventional

Funder types: Other

Identifiers

NCT06343467

A17-376

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Generic Implant

Experimental group

Description:

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

Treatment:

Device: Generic Volar Locking Plate

Conventional Implant

Active Comparator group

Description:

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.

Treatment:

Device: Conventional Volar Locking Plate