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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05523635
Other study ID # TA-01-2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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