A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT
Public ClinicalTrials.gov record NCT04015128. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04015128
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 11, 2019
- Primary completion
- Apr 15, 2026
- Completion
- Apr 15, 2026
- Last update posted
- Jul 7, 2026
2019 – 2026
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Cloud Orthopedic Associates, Ltd | Sartell | Minnesota | 56377 | — |
| Reno Orthopedic Clinic | Reno | Nevada | 89503 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| UC Health | Cincinnati | Ohio | 45229 | — |
| Regional One Health | Memphis | Tennessee | 38103 | — |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04015128, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04015128 live on ClinicalTrials.gov.