Femoral FracturePEGASUSNCT05523635
Post Market Clinical Evaluation of Gamma 4
An observational study of Femoral Fracture, run by Stryker Trauma and Extremities at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Fracture
- What is being tested?
- Gamma4 Nailing System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Mar 2023to 16 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
MetroHealth
Cleveland, Ohio, 44109
Inova Health Care Services
Falls Church, Virginia, 22042
SSM Health - Madison
Madison, Wisconsin, 53715
William Beaumont Hospital
Royal Oak, Michigan, 48073
UT Health
San Antonio, Texas, 78229
About this study
Official title: Post Market Clinical Evaluation of Gamma 4: Prospective, Multicenter, Follow-up Study (PEGASUS)
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.
Read the 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.
- Conditions
- Femoral Fracture
- Being tested
- Gamma4 Nailing System
- Keywords
- Fractures, Hip Fracture, Leg Injuries, Wounds and Injuries
- Medical subject headings
- Femoral Fractures, Fractures, Bone, Hip Fractures, Leg Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma4 Nailing SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Gamma4 Nailing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Consolidation via Clinical Assessment
Clinical consolidation is defined as no pain or tenderness when weight bearing
Measured: by 12 months
Bone Consolidation via Radiographic Assessment
Radiographic bony consolidation is defined as bridging of the fracture at three of four cortices.
Measured: by 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start6 Mar 2023
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FractureStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma and Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523635
- Sponsor's protocol ID
- TA-01-2022
- Acronym
- PEGASUS
- Status last verified
- Apr 2026
- First submitted
- 4 Aug 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Evaluation of Gamma 4: Prospective, Multicenter, Follow-up Study (PEGASUS)
- ClinicalTrials.gov ID
- NCT05523635
- Acronym / sponsor ID
- PEGASUS / TA-01-2022
- Conditions
- Femoral Fracture
- Keywords
- Fractures, Hip Fracture, Leg Injuries, Wounds and Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gamma 4 | – | Device: Gamma4 Nailing SystemSubjects in the clinical investigation will undergo placement of the Gamma4 Nailing System, according to the approved Instructions for Use and Operative Technique Manual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma4 Nailing SystemThe 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). | Device | Gamma 4 |
Primary outcome
Bone Consolidation via Clinical Assessment
Time frame: by 12 months
Clinical consolidation is defined as no pain or tenderness when weight bearing
Bone Consolidation via Radiographic Assessment
Time frame: by 12 months
Radiographic bony consolidation is defined as bridging of the fracture at three of four cortices.
3 secondary outcomes
Safety will be measured by capturing the incidence rate of device-related adverse events
Time frame: 12 months
SF-36v2® Physical Component Score and Mental Component Score (PCS & MCS)
Time frame: 12 months
Modified Harris Hip Score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma and Extremities
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fracture, run by Stryker Trauma and Extremities at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Consolidation via Clinical Assessment (time frame: by 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.