Status:
RECRUITING
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
Lead Sponsor:
Stryker Craniomaxillofacial
Collaborating Sponsors:
Qmed Consulting A/S
Conditions:
Cranioplasty
Craniofacial Abnormalities
Eligibility:
All Genders
42+ years
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 def...
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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.
- Subject who has an expected survival rate of less than 2 years, in the opinion of the investigator who takes consent.
Exclusion
Key Trial Info
Start Date :
February 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05362370
Start Date
February 1 2023
End Date
December 30 2027
Last Update
October 17 2025
Active Locations (13)
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1
University of Louisville 501 E. Broadway, Suite 210
Louisville, Kentucky, United States, 40202
2
Department of Neurological Surgery
New Brunswick, New Jersey, United States, 07101-1709
3
Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital
New York, New York, United States, 10032
4
Lewis Katz School of Medicine at Temple University, 3401 North Broad Street
Philadelphia, Pennsylvania, United States, 19140