Clinical trial NCT05523635: Post Market Clinical Evaluation of Gamma 4
Official title: Post Market Clinical Evaluation of Gamma 4: Prospective, Multicenter, Follow-up Study (PEGASUS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Femoral Fracture
Keywords: Fractures
Hip Fracture
Leg Injuries
Wounds and Injuries
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2022-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Consolidation via Clinical Assessment
timeFrame: by 12 months
measure: Bone Consolidation via Radiographic Assessment
timeFrame: by 12 months
Secondary outcomes:
measure: Safety will be measured by capturing the incidence rate of device-related adverse events
timeFrame: 12 months
measure: SF-36v2® Physical Component Score and Mental Component Score (PCS & MCS)
timeFrame: 12 months
measure: Modified Harris Hip Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: San Antonio
country: United States
facility: UT Health
state: Texas
city: Falls Church
country: United States
facility: Inova Health Care Services
state: Virginia
city: Madison
country: United States
facility: SSM Health - Madison
state: Wisconsin
Study officials:
affiliation: Stryker Trauma and Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: