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Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
Sponsor: Stryker Craniomaxillofacial
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.
Key Details
Gender
All
Age Range
42 Months - Any
Study Type
OBSERVATIONAL
Enrollment
110
Start Date
2023-02-01
Completion Date
2027-12-30
Last Updated
2025-10-20
Healthy Volunteers
No
Interventions
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).
Locations (13)
University of Louisville 501 E. Broadway, Suite 210
Louisville, Kentucky, United States
Department of Neurological Surgery
New Brunswick, New Jersey, United States
Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital
New York, New York, United States
Lewis Katz School of Medicine at Temple University, 3401 North Broad Street
Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA
Charleston, South Carolina, United States
Universitätsklinik für Neurochirurgie Auenbruggerplatz 29
Graz, Austria
Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9
Toulouse, Occitanie, France
APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré
Paris, Paris France, France
CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1
Nantes, Pays de la Loire Region, France
St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263
Hamm, Hamm, Germany
Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240
Dortmund, North Rhine-Westphalia, Germany
Servicio de Neurocirugía Hospital Universitario La Paz.
Madrid, Madrid, Spain
Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust
London, London, United Kingdom