Custom PEEK implant to restore or augment skull and facial bones
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
This trial will test Stryker's custom PEEK implants to restore or augment skull and facial bones in people with cranial or craniofacial defects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 42 Months and up |
| Sex | All |
| Sponsor | Stryker Craniomaxillofacial Industry-sponsored |
| Locations | 13 sites (Louisville, Kentucky and 12 other locations) |
| Trial ID | NCT05362370 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multi-center, observational post-market follow-up of patient-specific PEEK implants made from CT data and surgeon input to fill bony voids in the cranium and craniofacial skeleton. Up to 110 participants treated per routine clinical practice at participating sites in the United States and Europe will be followed for 24 months after implantation. The primary safety endpoint is implant infection rate, with additional assessments of device performance and long-term clinical benefit. Data are collected in a real-world setting without altering standard surgical care pathways.
Who should consider this trial
Good fit: Ideal candidates are patients (age ≥3.5 years in the USA, ≥12 years in Europe) who need augmentation or restoration of cranial or craniofacial bony or soft-tissue defects and are eligible for a PEEK customized implant per routine clinical practice.
Not a fit: Patients with active local or systemic infection, known allergy or sensitivity to plastics/polymers, severely compromised bone that cannot support an implant, or certain neuromuscular disorders may not benefit from implantation.
Why it matters
Potential benefit: If successful, the implants could provide a durable, anatomically matched restoration of bone contours and reduce deformity-related functional or cosmetic problems.
How similar studies have performed: Patient-specific PEEK cranial and craniofacial implants are already used in clinical practice and published reports generally show favorable outcomes, but long-term, multi-center post-market data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Louisville, Kentucky and 12 other locations
- University of Louisville 501 E. Broadway, Suite 210 — Louisville, Kentucky, United States (Enrolling_by_invitation)
- Department of Neurological Surgery — New Brunswick, New Jersey, United States (Enrolling_by_invitation)
- Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital — New York, New York, United States (Recruiting)
- Lewis Katz School of Medicine at Temple University, 3401 North Broad Street — Philadelphia, Pennsylvania, United States (Enrolling_by_invitation)
- Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA — Charleston, South Carolina, United States (Recruiting)
- Universitätsklinik für Neurochirurgie Auenbruggerplatz 29 — Graz, Austria (Recruiting)
- Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9 — Toulouse, Occitanie, France (Recruiting)
- APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré — Paris, Paris France, France (Recruiting)
- CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1 — Nantes, Pays de la Loire Region, France (Enrolling_by_invitation)
- St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263 — Hamm, Hamm, Germany (Recruiting)
- Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240 — Dortmund, North Rhine-Westphalia, Germany (Recruiting)
- Servicio de Neurocirugía Hospital Universitario La Paz. — Madrid, Madrid, Spain (Recruiting)
- Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust — London, London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Ilka Meinert, Ph.D
- Email: Ilka.meinert@stryker.com
- Phone: +49 170 384 5636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.