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N/A N=66 Randomized Single-blind Treatment

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

Distal Radius Fractures

Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: 90-day Reoperation Rate — 0; 0 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Generic Volar Locking Plate (Device); Conventional Volar Locking Plate (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
HealthPartners Institute
Primary completion
Apr 2023

Outcome Measures

OutcomeResultp-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

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.

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
View full record on ClinicalTrials.gov →

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.

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