Stryker's PEEK Customized Implant: The PEEK Customized Implants will be used in this patient cohort for augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
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 (up to 24-months) of study participants.
| Facility | City | Region | Status |
|---|---|---|---|
| University of Louisville 501 E. Broadway, Suite 210 | Louisville | Kentucky | |
| Department of Neurological Surgery | New Brunswick | New Jersey | |
| Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital | New York | New York | |
| Lewis Katz School of Medicine at Temple University, 3401 North Broad Street | Philadelphia | Pennsylvania | |
| Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA | Charleston | South Carolina | |
| Universitätsklinik für Neurochirurgie Auenbruggerplatz 29 | Graz | Austria | |
| Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9 | Toulouse | Occitanie | |
| APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré | Paris | Paris France | |
| CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1 | Nantes | Pays de la Loire Region | |
| St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263 | Hamm | Hamm | |
| Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240 | Dortmund | North Rhine-Westphalia | |
| Servicio de Neurocirugía Hospital Universitario La Paz. | Madrid | Madrid | |
| Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust | London | London |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05362370 on ClinicalTrials.gov ↗ ← All trials in the UK