Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
Stryker Craniomaxillofacial
110 participants
Feb 1, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria7
- 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.
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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).
Locations(13)
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NCT05362370