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NCT05362370 · ClinicalTrials.gov registry record
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
A clinical trial of Craniofacial Injuries and Cranioplasty, sponsored by Stryker Craniomaxillofacial.
- Recruiting
- Registry status
- 110
- Enrollment target
- 13
- Study locations
NCT05362370: Recruiting study of Craniofacial Injuries and Cranioplasty, sponsored by Stryker Craniomaxillofacial.
NCT05362370 is a study of Craniofacial Injuries and Cranioplasty that is actively recruiting participants, run by Stryker Craniomaxillofacial. The registered enrollment target is 110 participants. The trial reports 13 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05362370, a study of Craniofacial Injuries and Cranioplasty, is actively recruiting participants, sponsored by Stryker Craniomaxillofacial.
- RECRUITING
- Registry status
- 110 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-center trial with a long-term follow-up (24 months) of study participants.
Primary Outcome
Assessment of rate of infection associated with Stryker's PEEK Customized Implants.
Conditions Studied
Interventions
- DEVICE Stryker's PEEK Customized Implant
Study Locations (13)
Kentucky
- University of Louisville 501 E. Broadway, Suite 210 - Louisville
New Jersey
- Department of Neurological Surgery - New Brunswick
New York
- Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital - New York
Pennsylvania
- Lewis Katz School of Medicine at Temple University, 3401 North Broad Street - Philadelphia
South Carolina
- Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA - Charleston
Other
- Universitätsklinik für Neurochirurgie Auenbruggerplatz 29 - Graz
Occitanie
- Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9 - Toulouse
Paris France
- APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré - Paris
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2027-12-30 |
What NCT05362370 shows while recruiting
NCT05362370 is an observational study that tracks outcomes without assigning an intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap.
The record links to 3 conditions, with Craniofacial Injuries appearing as the primary indexed condition, and to 1 intervention - of which Stryker's PEEK Customized Implant is the first listed.
NCT05362370 lists 13 locations in 13 states (Kentucky, New Jersey, New York).
Frequently Asked Questions
What is clinical trial NCT05362370 about?
NCT05362370 is a clinical study titled "Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness". The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-cen...
What is the current status of trial NCT05362370?
This trial is currently recruiting. The enrollment target is 110 participants. The study started on 2023-02-01. Estimated completion is 2027-12-30.
What conditions does trial NCT05362370 study?
This clinical trial studies the following conditions: Craniofacial Injuries, Cranioplasty, Craniofacial Abnormalities.
What interventions are being tested in trial NCT05362370?
The interventions under investigation include: Stryker's PEEK Customized Implant (DEVICE).
Who is sponsoring clinical trial NCT05362370?
This trial is sponsored by Stryker Craniomaxillofacial, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05362370 being conducted?
This trial has 13 study locations across Kentucky, New Jersey, New York, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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