Post Market Clinical Evaluation of Gamma 4 (PEGASUS)

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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Fracture
• Intervention / Treatment: Device: Gamma4 Nailing System

Detailed Description

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 (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Health Care Services
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • SSM Health - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Approximately 100 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for treatment of femoral fractures and deformities with a cephalomedullary nail will be evaluated for clinical investigation participation based on the eligibility criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gamma 4; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stryker Trauma and Extremities
• Investigators: Study Director: Rebecca Gibson, Stryker Trauma and Extremities

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): October 16, 2025
• Study Completion (Actual): October 16, 2025

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hip Fracture; Fractures; Wounds and Injuries; Leg Injuries
• Additional Relevant MeSH Terms: Hip Injuries; Fractures, Bone; Femoral Fractures; Wounds and Injuries; Hip Fractures; Leg Injuries
• Other Study ID Numbers: TA-01-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes