Post Market Clinical Evaluation of Gamma 4

NCT05523635 | Completed FDA Device

• 1 other identifier: TA-01-2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Femoral Fracture

Keywords

Fractures; Hip Fracture; Leg Injuries; Wounds and Injuries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Safety will be measured by capturing the incidence rate of device-related adverse events

  12 months

• SF-36v2® Physical Component Score and Mental Component Score (PCS & MCS)

  12 months

• Modified Harris Hip Score

  12 months

Study Arms (1)

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

Interventions

Gamma4 Nailing System DEVICE

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).

Gamma 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (5)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MetroHealth

Cleveland, Ohio, 44109, United States

Location

UT Health

San Antonio, Texas, 78229, United States

Location

Inova Health Care Services

Falls Church, Virginia, 22042, United States

Location

SSM Health - Madison

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Femoral Fractures; Fractures, Bone; Hip Fractures; Leg Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Hip Injuries

Study Officials

• Rebecca Gibson

  Stryker Trauma and Extremities

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 31, 2022
• Study Start: March 6, 2023
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)