Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
1 other identifier
observational
110
6 countries
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2023
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
May 5, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
October 20, 2025
October 1, 2025
4.7 years
April 12, 2022
October 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Infection Rate
Assessment of rate of infection associated with Stryker's PEEK Customized Implants.
24 months post-operative
Secondary Outcomes (9)
Incidence of device related serious adverse events (SAEs)
24 months post-operative
Ability to place the Customized Implant during surgery leading to good aesthetic outcome
24 months post-operative
Rate of implant failure
24 months post-operative
Quality of life questionnaire
24 months post-operative
Length of hospitalisation
Up to 1 month
- +4 more secondary outcomes
Study Arms (1)
Cohort 1
Participants will receive a Stryker PEEK Customized Implant
Interventions
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).
Eligibility Criteria
Patients with cranial and craniofacial defects requiring augmentation and/or restoration, e.g. following tumor resection, trauma, vascular conditions, or stroke requiring craniectomy, due to previously failed cranioplasty, or bone flap resorption.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stryker Craniomaxillofaciallead
- Qmed Consulting A/Scollaborator
Study Sites (13)
University of Louisville 501 E. Broadway, Suite 210
Louisville, Kentucky, 40202, United States
Department of Neurological Surgery
New Brunswick, New Jersey, 07101-1709, United States
Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital
New York, New York, 10032, United States
Lewis Katz School of Medicine at Temple University, 3401 North Broad Street
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA
Charleston, South Carolina, 29425, United States
Universitätsklinik für Neurochirurgie Auenbruggerplatz 29
Graz, 8036, Austria
Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9
Toulouse, Occitanie, TSA 40031 - 31059, France
APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré
Paris, Paris France, 75010, France
CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1
Nantes, Pays de la Loire Region, 44093, France
St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263
Hamm, Hamm, 59073, Germany
Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240
Dortmund, North Rhine-Westphalia, 44145, Germany
Servicio de Neurocirugía Hospital Universitario La Paz.
Madrid, Madrid, 28046, Spain
Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust
London, London, SW7 2AZ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2022
First Posted
May 5, 2022
Study Start
February 1, 2023
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share