Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
Running, not enrolling
Conditions studied: Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries
In brief
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.
Key facts
- Study ID
- NCT05362370
- Run by
- Stryker Craniomaxillofacial
- People needed
- 99
- Starts
- 2023-02-01
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-05-29
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is eligible for a PEEK customized implant as per routine clinical practice.
- Subject is 12 years of age or older (Europe only).
- Subject is 3.5 years of age or older (USA only).
- Adult subjects able to give consent.
- Subjects under the age of 18 will have a legal representative or parents (France - both parents must sign) to provide informed consent.
- Subjects who are unable to give consent themselves but have a legally authorized representative that may consent on their behalf.
You may not qualify if…
- Subject has an active systemic or local infection.
- Subject has known allergy to plastic or polymers and/or known sensitivity to foreign bodies.
- Comprised bone due to poor blood supply, disease, infection or prior implantation, which would not allow adequate support or fixation of the implant.
- Mental or neuromuscular disorder which could create an unacceptable risk of implant instability or implant fixation failure, or complications in postoperative care.
- Knowingly pregnant or nursing women.
- Concomitant participation in other clinical trials related to cranioplasty.
- Subject who has an expected survival rate of less than 2 years, in the opinion of the investigator who takes consent.
Where it is running
- 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
Full record on ClinicalTrials.gov
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