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.
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the Gamma 4 System. Enrolled subjects will undergo an initial assessment, with follow-up evaluations at 3 Months, 6 Months, and 12 Months after the index procedure. The primary endpoint of this clinical investigation is demonstration of bone consolidation by 12 months, as measured by the Investigator. Secondary endpoints will include safety through reporting the incidence of device related intra-operative and post-operative adverse events by 12 months, patient reported outcome measures (SF-35v2 and Modified Harris Hip Score), and other specific health outcomes. Efficacy will be assessed through non-inferiority of bone consolidation proportion compared to the pooled literature control, as well as the SF-36 score results by 12 months.
Study Type
OBSERVATIONAL
Enrollment
100
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).
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
Bone Consolidation via Clinical Assessment
Clinical consolidation is defined as no pain or tenderness when weight bearing
Time frame: by 12 months
Bone Consolidation via Radiographic Assessment
Radiographic bony consolidation is defined as bridging of the fracture at three of four cortices.
Time frame: by 12 months
Safety will be measured by capturing the incidence rate of device-related adverse events
Incidence of device related intra-operative and post-operative Adverse Events/incidents by 12 months.
Time frame: 12 months
SF-36v2® Physical Component Score and Mental Component Score (PCS & MCS)
The SF-36 PCS is a self-report measure of health status. SF-36 Physical Component Summary scores range from 0 to 100; higher SF-36 score results are linked to better subject results. Efficacy/performance at 12 months will be measured by the SF-36 Physical Component Score (PCS) compared to the pooled literature controls.
Time frame: 12 months
Modified Harris Hip Score
The modified Harris Hip Score is a hip-specific questionnaire which evaluates hip pain and function. It is a commonly used and validated tool. Efficacy/performance at 12 months will be measured by the modified Harris Hip Score compared to the pooled literature controls.
Time frame: 12 months
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