Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343467
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2024-03-14
Brief Title:
Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Generic Volar Locking Plate Use in Distal Radius Fractures A Prospective Randomized Study to Evaluate Clinical Outcomes and Cost Reduction
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 surgeons 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 institutions 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 Cohens d08 At a Type I error rate of 005 a power of 80 and a 11 group allocation the estimated sample size was 36 patients 18 generic VLPs vs 18 conventional VLPs Statistical significance was set to p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None