Femoral FractureNCT04015128
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT
An observational study of Femoral Fracture, run by Stryker Trauma and Extremities at 6 sites in United States.
Trial summary
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail GT of the T2… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Femoral Fracture
- What is being tested?
- Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Sep 2019to 16 Apr 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 50 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 will be evaluated for clinical investigation participation based on the eligibility criteria listed above.
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;
- Subject is intended to be treated with the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System in accordance with the following legally cleared/ approved Indications for Use:
- Indications for Use approved Outside of Europe include:
- Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
- Femoral fixation required as a result of pathological disease
Show all 14Show fewer
- Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty
- Nonunions and malunions
- Fractures involving osteopenic and osteoporotic 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;
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
UC Health
Cincinnati, Ohio, 45229
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Regional One Health
Memphis, Tennessee, 38103
NYU Langone Medical Center
New York, New York, 10016
Reno Orthopedic Clinic
Reno, Nevada, 89503
St. Cloud Orthopedic Associates, Ltd
Sartell, Minnesota, 56377
About this study
Official title: A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail Greater Trochanter (GT) of the T2 Alpha Femur Antegrade GT/PF Nailing System
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System.
Total duration of enrollment, 12 month follow-up and analysis is expected to take 25 months. The clinical investigation has been designed to follow the surgeon's standard of care for femur fractured subjects, in addition to a 12 month follow-up visit.
The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.
Read the detailed description
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System. Efficacy/performance of the procedure will be measured by an equal or greater (non-inferior) Lower Extremity Measure (LEM) score result of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature at 12 months.
In addition, demonstration of bone consolidation in correct alignment will be measured by Investigator assessment by 12 months. Safety of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System will be demonstrated through reporting of device related intra-operative and post-operative Adverse Events/incidents by 12 months.
- Conditions
- Femoral Fracture
- Being tested
- Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing SystemDevice
The T2 Alpha Femur Antegrade GT / PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
| Study group | Role | What they receive |
|---|---|---|
| T2 Alpha Femoral Nail GT | Subjects in the clinical investigation will undergo placement of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System which allows for insertion through the tip of the greater trochanter, according to the approved Instructions for Use and Operative Technique Manual. Receives: Device: Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Measure (LEM)
The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature
Measured: 12 months
Secondary outcomes (2)
Safety will be measured by capturing the incidence rate of device-related adverse events
Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses.
Measured: 12 months
Efficacy/Performance will be measured by demonstration of bone consolidation
Bone consolidation will be assessed by 12 months as measured by Investigator assessment.
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 posted10 Jul 2019
- Study start12 Sep 2019
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
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
- 66 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, rebecca.gibson@stryker.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015128
- Sponsor's protocol ID
- T2 Alpha Femur Antegrade GT
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2019
- Last updated
- 8 Jul 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail Greater Trochanter (GT) of the T2 Alpha Femur Antegrade GT/PF Nailing System
- ClinicalTrials.gov ID
- NCT04015128
- Acronym / sponsor ID
- T2 Alpha Femur Antegrade GT
- Conditions
- Femoral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 10 Jul 2019 (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 investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System.
Total duration of enrollment, 12 month follow-up and analysis is expected to take 25 months. The clinical investigation has been designed to follow the surgeon's standard of care for femur fractured subjects, in addition to a 12 month follow-up visit.
The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.
Detailed description
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System. Efficacy/performance of the procedure will be measured by an equal or greater (non-inferior) Lower Extremity Measure (LEM) score result of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature at 12 months.
In addition, demonstration of bone consolidation in correct alignment will be measured by Investigator assessment by 12 months. Safety of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System will be demonstrated through reporting of device related intra-operative and post-operative Adverse Events/incidents by 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2 Alpha Femoral Nail GT | – | Device: Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing SystemSubjects in the clinical investigation will undergo placement of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System which allows for insertion through the tip of the greater trochanter, according to the approved Instructions for Use and Operative Technique Manual. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 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 will be evaluated for clinical investigation participation based on the eligibility criteria listed above.
Key inclusion criteria (14 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;
- Subject is intended to be treated with the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System in accordance with the following legally cleared/ approved Indications for Use:
- Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
- Femoral fixation required as a result of pathological disease
Key exclusion criteria (2 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;
- 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).
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 |
|---|---|---|
| Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing SystemThe T2 Alpha Femur Antegrade GT / PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved. | Device | T2 Alpha Femoral Nail GT |
Primary outcome
Lower Extremity Measure (LEM)
Time frame: 12 months
The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature
2 secondary outcomes
Safety will be measured by capturing the incidence rate of device-related adverse events
Time frame: 12 months
Efficacy/Performance will be measured by demonstration of bone consolidation
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 8 Jul 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
rebecca.gibson@stryker.com
6 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 6 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 14 inclusion and 2 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Lower Extremity Measure (LEM) (time frame: 12 months). 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 8 Jul 2026.