Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
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.
Description
Stryker's PEEK Customized Implants are patient-specific implants based on CT-data of the individual patient and input of the surgeon. The implants are fabricated from Polyetheretherketone (PEEK) and intended to be used to fill bony voids in the cranial and craniofacial region (e.g. cranium, orbital rim, zygoma, and adjacent bone). This observational post-market clinical follow-up (PMCF) is designed to confirm the safety, performance and clinical benefit of Stryker's PEEK Customized Implants for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and cranio…
Eligibility
- Age range
- 3+ years
- Sex
- All
- 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.…
Interventions
- DeviceStryker'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 210Louisville, Kentucky
- Department of Neurological SurgeryNew Brunswick, New Jersey
- Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian HospitalNew York, New York
- Lewis Katz School of Medicine at Temple University, 3401 North Broad StreetPhiladelphia, Pennsylvania
- Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USACharleston, South Carolina
- Universitätsklinik für Neurochirurgie Auenbruggerplatz 29Graz