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Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
NCT05362370 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05362370
The ClinicalTrials.gov registry entry for NCT05362370 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stryker Craniomaxillofacial, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05362370 reports 13 study locations spanning 13 distinct geographic areas — top geographies include Kentucky, New Jersey, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05362370?
The interventions under investigation include: Stryker's PEEK Customized Implant (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05362370?
This trial is sponsored by Stryker Craniomaxillofacial, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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