Post Market Clinical Evaluation of Gamma 4

Femoral Fracture Clinical Trial

— PEGASUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05523635
• Other study ID #: TA-01-2022
• Status: Recruiting
• Start date: March 6, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Stryker Trauma GmbH
• Contact: Rebecca Gibson
• Phone: 919-915-4426
• Email: rebecca.gibson[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fracture
• Femoral Fractures

Intervention

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

Country	Name	City	State
United States	MetroHealth	Cleveland	Ohio
United States	Inova Health Care Services	Falls Church	Virginia
United States	SSM Health - Madison	Madison	Wisconsin
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	UT Health	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Consolidation via Clinical Assessment	Clinical consolidation is defined as no pain or tenderness when weight bearing	by 12 months
Primary	Bone Consolidation via Radiographic Assessment	Radiographic bony consolidation is defined as bridging of the fracture at three of four cortices.	by 12 months
Secondary	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
Secondary	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
Secondary	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