Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performa… (NCT05362370) | Clinical Trial Compass
RecruitingNot Applicable
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
United States110 participantsStarted 2023-02-01
Plain-language 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.
Who can participate
Age range42 Months
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.