Post Market Clinical Evaluation of Gamma 4
Completed
Conditions studied: Femoral Fracture
In brief
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.
Key facts
- Study ID
- NCT05523635
- Run by
- Stryker Trauma and Extremities
- People needed
- 100
- Starts
- 2023-03-06
- Expected to finish
- 2025-10-16
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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 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.
Where it is running
- William Beaumont Hospital — Royal Oak, Michigan, United States
- MetroHealth — Cleveland, Ohio, United States
- UT Health — San Antonio, Texas, United States
- Inova Health Care Services — Falls Church, Virginia, United States
- SSM Health - Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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