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Clinical Trials in the UK / NCT05362370
Active, not recruiting Observational

Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness

NCT05362370 · tracked via the Priya Life Science UK tracker
Sponsor
Stryker Craniomaxillofacial
Phase
Observational
Started
2023-02-01
Last updated
2026-05-29

Condition(s) studied

CranioplastyCraniofacial AbnormalitiesCraniofacial Injuries

Investigational drug(s) / intervention(s)

Stryker's PEEK Customized Implant

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).

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 (up to 24-months) of study participants.

Eligibility

Sex
ALL
Min age
42 Months
Max age
Healthy volunteers
No
Inclusion Criteria 1. Subject is eligible for a PEEK customized implant as per routine clinical practice. 2. Subject is 12 years of age or older (Europe only). 3. Subject is 3.5 years of age or older (USA only). 4. Adult subjects able to give consent. 5. Subjects under the age of 18 will have a legal representative or parents (France - both parents must sign) to provide informed consent. 6. Subjects who are unable to give consent themselves but have a legally authorized representative that may consent on their behalf. Exclusion Criteria 1. Subject has an active systemic or local infection. 2. Subject has known allergy to plastic or polymers and/or known sensitivity to foreign bodies. 3. Comprised bone due to poor blood supply, disease, infection or prior implantation, which would not allow adequate support or fixation of the implant. 4. Mental or neuromuscular disorder which could create an unacceptable risk of implant instability or implant fixation failure, or complications in postoperative care. 5. Knowingly pregnant or nursing women. 6. Concomitant participation in other clinical trials related to cranioplasty. 7. Subject who has an expected survival rate of less than 2 years, in the opinion of the investigator who takes consent.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
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
Official registry record

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