Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05523635 · ClinicalTrials.gov registry record
Post Market Clinical Evaluation of Gamma 4
A clinical trial of Femoral Fracture, sponsored by Stryker Trauma and Extremities.
- Active
- Registry status
- 100
- Enrollment target
- 5
- Study locations
NCT05523635: Active study of Femoral Fracture, sponsored by Stryker Trauma and Extremities.
NCT05523635 is a study of Femoral Fracture that is active but no longer recruiting, run by Stryker Trauma and Extremities. The registered enrollment target is 100 participants, above the 48-participant average among 6 other Femoral Fracture trials with a reported enrollment target (108% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05523635, a study of Femoral Fracture, is active but no longer recruiting, sponsored by Stryker Trauma and Extremities.
- ACTIVE NOT RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Clinical consolidation is defined as no pain or tenderness when weight bearing
Conditions Studied
Interventions
- DEVICE Gamma4 Nailing System
Study Locations (5)
Michigan
- William Beaumont Hospital - Royal Oak
Ohio
- MetroHealth - Cleveland
Texas
- UT Health - San Antonio
Virginia
- Inova Health Care Services - Falls Church
Wisconsin
- SSM Health - Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-03-06 |
| Est. Completion | 2025-10-31 |
What the registry record for NCT05523635 still lists
NCT05523635 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 48-participant average among 6 other Femoral Fracture trials with a reported enrollment target (108% higher).
The record links to 1 condition, with Femoral Fracture appearing as the primary indexed condition, and to 1 intervention - of which Gamma4 Nailing System is the first listed.
NCT05523635 lists 5 locations in 5 states (Michigan, Ohio, Texas).
Frequently Asked Questions
What is clinical trial NCT05523635 about?
NCT05523635 is a clinical study titled "Post Market Clinical Evaluation of Gamma 4". 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...
What is the current status of trial NCT05523635?
This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2023-03-06. Estimated completion is 2025-10-31.
What conditions does trial NCT05523635 study?
This clinical trial studies the following conditions: Femoral Fracture.
What interventions are being tested in trial NCT05523635?
The interventions under investigation include: Gamma4 Nailing System (DEVICE).
Who is sponsoring clinical trial NCT05523635?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05523635 being conducted?
This trial has 5 study locations across Michigan, Ohio, Texas, Virginia, Wisconsin. 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
-
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
ACTIVE NOT RECRUITING
-
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT
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
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
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