Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04015128 · ClinicalTrials.gov registry record
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT
A clinical trial of Femoral Fracture, sponsored by Stryker Trauma and Extremities.
- Active
- Registry status
- 66
- Enrollment target
- 6
- Study locations
NCT04015128: Active study of Femoral Fracture, sponsored by Stryker Trauma and Extremities.
NCT04015128 is a study of Femoral Fracture that is active but no longer recruiting, run by Stryker Trauma and Extremities. The registered enrollment target is 66 participants, above the 54-participant average among 6 other Femoral Fracture trials with a reported enrollment target (22% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04015128, a study of Femoral Fracture, is active but no longer recruiting, sponsored by Stryker Trauma and Extremities.
- ACTIVE NOT RECRUITING
- Registry status
- 66 participants
- Enrollment target
- 6
- Study locations
Study 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 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System
Study Locations (6)
Minnesota
- St. Cloud Orthopedic Associates, Ltd - Sartell
Nevada
- Reno Orthopedic Clinic - Reno
New York
- NYU Langone Medical Center - New York
Ohio
- UC Health - Cincinnati
Tennessee
- Regional One Health - Memphis
Virginia
- Inova Fairfax Medical Campus - Falls Church
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2026-05 |
What the registry record for NCT04015128 still lists
NCT04015128 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 54-participant average among 6 other Femoral Fracture trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Femoral Fracture appearing as the primary indexed condition, and to 1 intervention - of which Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System is the first listed.
NCT04015128 lists 6 locations in 6 states (Minnesota, Nevada, New York).
Frequently Asked Questions
What is clinical trial NCT04015128 about?
NCT04015128 is a clinical study titled "A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT". 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 Nai...
What is the current status of trial NCT04015128?
This trial is currently active not recruiting. The enrollment target is 66 participants. The study started on 2019-09-12. Estimated completion is 2026-05.
What conditions does trial NCT04015128 study?
This clinical trial studies the following conditions: Femoral Fracture.
What interventions are being tested in trial NCT04015128?
The interventions under investigation include: Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System (DEVICE).
Who is sponsoring clinical trial NCT04015128?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04015128 being conducted?
This trial has 6 study locations across Minnesota, Nevada, New York, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Femoral Fracture
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
RECRUITING · NA
-
Essential Amino Acid Supplementation for Femoral Fragility Fractures
RECRUITING · Phase 2
-
A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects
RECRUITING
-
Post Market Clinical Evaluation of Gamma 4
ACTIVE NOT RECRUITING
-
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
ACTIVE NOT RECRUITING
-
Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02584244 · 66 participants · Phase 1
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
- NCT03067051 · 66 participants · Phase 1
Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
- NCT03754725 · 66 participants · Phase 1
Ferritin and Iron Burden in SAH sIRB
- NCT03875378 · 66 participants · Phase 2
Transdermal Estrogen in Women With Anorexia Nervosa
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI