Post Market Clinical Evaluation of Gamma 4

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post Market Clinical Evaluation of Gamma 4: Prospective, Multicenter, Follow-up Study (PEGASUS)

Conditions
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Femoral Fracture

Intervention / Treatment
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* Device: Gamma4 Nailing System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a male or non-pregnant female age 18 years or older at the time of surgery; Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan; and Subject has or is intended to be treated with the Gamma 4 System in accordance with its legally approved Indication for Use (IFU). Indication For Use in the United States and Canada: The Gamma4 System 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). Exclusion Criteria: Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results Subject with exclusion criteria required by local law Subject who is, or will be, inaccessible for follow-up Per the Investigator, the subject is in poor general health or undergoing any concurrent disease that would place the subject in excessive risk to surgery (i.e., significant circulatory problems, cardiac disease). Any active or suspected latent infection or marked local inflammation in or about the affected area Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices Material sensitivity, documented or suspected Patients having inadequate tissue coverage over the operative site Implant utilization that would interfere with anatomical structures or physiological performance Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care Other medical or surgical conditions which would preclude the potential benefit of surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gamma 4<br>Subjects in the clinical investigation will undergo placement of the Gamma4 Nailing System, according to the approved Instructions for Use and Operative Technique Manual | Device: Gamma4 Nailing System<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Consolidation via Clinical Assessment | Clinical consolidation is defined as no pain or tenderness when weight bearing | by 12 months | 
| Bone Consolidation via Radiographic Assessment | Radiographic bony consolidation is defined as bridging of the fracture at three of four cortices. | by 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractures, Hip Fracture, Leg Injuries, Wounds and Injuries