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Post Market Clinical Evaluation of Gamma 4
Sponsor: Stryker Trauma and Extremities
Summary
This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment. It is anticipated that a total of 100 subjects will be enrolled at five sites. Total duration of enrollment, 12 month follow-up and analysis is expected to take approximately 30 months. The clinical investigation has been designed to follow the surgeon's standard of care for subjects treated with a cephalomedullary nail for femoral fractures or and deformities, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is demonstration of bone consolidation by 12 months.
Official title: Post Market Clinical Evaluation of Gamma 4: Prospective, Multicenter, Follow-up Study (PEGASUS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2023-03-06
Completion Date
2025-10-31
Last Updated
2025-03-21
Healthy Volunteers
No
Conditions
Interventions
Gamma4 Nailing System
The Gamma4 Nailing System is is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).
Locations (5)
William Beaumont Hospital
Royal Oak, Michigan, United States
MetroHealth
Cleveland, Ohio, United States
UT Health
San Antonio, Texas, United States
Inova Health Care Services
Falls Church, Virginia, United States
SSM Health - Madison
Madison, Wisconsin, United States