N/A
Completed N=66
Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost?
Distal Radius Fractures
Source: ClinicalTrials.gov NCT06343467 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: 90-day Reoperation Rate — 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 90-day Reoperation Rate |
0; 0 | — |
| PRIMARY 90-day Readmission Rate |
0; 0 | — |
| PRIMARY 90-day Mortality Rate |
0; 0 | — |
| SECONDARY Implant Cost |
702.38; 1348.61 | — |
| SECONDARY Tourniquet Time |
49.05; 45.06 | — |
| SECONDARY Estimated Blood Loss |
13.3; 13.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT06343467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.