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

Not Applicable

Completed

Conditions: Distal Radius Fractures

Registration Number: NCT06343467

Lead Sponsor: HealthPartners Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
90-day Readmission Rate	Within 90 days postoperatively	Readmission to the hospital for any reason postoperatively within 90 days after the date of surgery.
90-day Reoperation Rate	Within 90 days postoperatively	Reoperation for any reason postoperatively within 90 days after the date of surgery.
90-day Mortality Rate	Within 90 days postoperatively	Patient death at any point within 90 days after the date of surgery.

Secondary Outcome Measures

Name	Time	Method
Implant Cost	Day of Surgery	The total cost of implants used in the procedure, including screws, pegs, volar locking plates, and disposable implants.
Estimated Blood Loss	Day of Surgery	Estimated blood loss for the surgical case as reported by the surgeon in milliliters.
Tourniquet Time	From tourniquet inflation to deflation during the procedure.	The total time in minutes from tourniquet inflation to deflation for a surgical case.