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ACTIVE NOT RECRUITING
NCT05523635

Post Market Clinical Evaluation of Gamma 4

Sponsor: Stryker Trauma and Extremities

View on ClinicalTrials.gov

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

Interventions

DEVICE

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