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NCT05019664 · ClinicalTrials.gov registry record
Affixus Natural Nail System Humeral Nail PMCF
A clinical trial of Humeral Fractures and Humeral Fractures, Proximal, sponsored by Zimmer Biomet.
- Recruiting
- Registry status
- 100
- Enrollment target
- 5
- Study locations
NCT05019664: Recruiting study of Humeral Fractures and Humeral Fractures, Proximal, sponsored by Zimmer Biomet.
NCT05019664 is a study of Humeral Fractures and Humeral Fractures, Proximal that is actively recruiting participants, run by Zimmer Biomet. The registered enrollment target is 100 participants. The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05019664, a study of Humeral Fractures and Humeral Fractures, Proximal, is actively recruiting participants, sponsored by Zimmer Biomet.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 5
- Study locations
Study Summary
A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.
Primary Outcome
The primary endpoint is bone union after 12 months since surgery. (Bone union defined as no pain or tenderness at the site, and strong enough to allow normal activities.)
Conditions Studied
Interventions
- DEVICE humeral fracture
Study Locations (5)
Other
- UZ Leuven - Traumatology Department - Leuven
- Hospital de la Santa Creu i Sant Pau - Barcelona
- General Foundation of the University of Valladolid - Valladolid
Texas
- University of Texas Health Science Center at San Antonio - San Antonio
Thurgau
- Kantonsspital Frauenfeld - Frauenfeld
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-08-29 |
| Est. Completion | 2027-08 |
What NCT05019664 shows while recruiting
NCT05019664 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.
The record links to 2 conditions, with Humeral Fractures appearing as the primary indexed condition, and to 1 intervention - of which humeral fracture is the first listed.
NCT05019664 lists 5 locations in 3 states (Other, Texas, Thurgau).
Frequently Asked Questions
What is clinical trial NCT05019664 about?
NCT05019664 is a clinical study titled "Affixus Natural Nail System Humeral Nail PMCF". A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.
What is the current status of trial NCT05019664?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2022-08-29. Estimated completion is 2027-08.
What conditions does trial NCT05019664 study?
This clinical trial studies the following conditions: Humeral Fractures, Humeral Fractures, Proximal.
What interventions are being tested in trial NCT05019664?
The interventions under investigation include: humeral fracture (DEVICE).
Who is sponsoring clinical trial NCT05019664?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05019664 being conducted?
This trial has 5 study locations across Texas, Thurgau. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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