Craniofacial Abnormalities Clinical Trial
Official title:
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
Verified date | October 2023 |
Source | Stryker Craniomaxillofacial |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 110 |
Est. completion date | December 30, 2025 |
Est. primary completion date | March 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 42 Months and older |
Eligibility | 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. 2. Subject has known allergy to plastic or polymers and/or known sensitivity to foreign bodies. 3. Comprised bone due to poor blood supply, disease, infection or prior implantation, which would not allow adequate support or fixation of the implant. 4. Mental or neuromuscular disorder which could create an unacceptable risk of implant instability or implant fixation failure, or complications in postoperative care. 5. Knowingly pregnant or nursing women. 6. Concomitant participation in other clinical trials related to cranioplasty. 7. Subject who has an expected survival rate of less than 2 years, in the opinion of the investigator who takes consent. |
Country | Name | City | State |
---|---|---|---|
Austria | Universitätsklinik für Neurochirurgie Auenbruggerplatz 29 | Graz | |
France | Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9 | Toulouse | Occitanie |
Germany | Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240 | Dortmund | Nordrhein-Westfalen |
Germany | St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263 | Hamm | |
Spain | Servicio de Neurocirugía Hospital Universitario La Paz. | Madrid | |
United Kingdom | Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust | London | |
United States | University of Louisville 501 E. Broadway, Suite 210 | Louisville | Kentucky |
United States | Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital | New York | New York |
United States | Lewis Katz School of Medicine at Temple University, 3401 North Broad Street | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Stryker Craniomaxillofacial | Qmed Consulting A/S |
United States, Austria, France, Germany, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infection Rate | Assessment of rate of infection associated with Stryker's PEEK Customized Implants. | 24 months post-operative | |
Secondary | Incidence of device related serious adverse events (SAEs) | Incidence of device related SAEs up to 24 months post implantation | 24 months post-operative | |
Secondary | Ability to place the Customized Implant during surgery leading to good aesthetic outcome | Assessment of success of placement by the surgeon as determined by the ability to close the defect effectively, even with modification of implant | 24 months post-operative | |
Secondary | Rate of implant failure | Rate of implant failure leading to explantation | 24 months post-operative | |
Secondary | Quality of life questionnaire | Outcome of Short Form health survey-12 (SF-12) quality of life questionnaire | 24 months post-operative | |
Secondary | Length of hospitalisation | Time duration after surgery until hospital discharge | Up to 1 month | |
Secondary | Persistent temporal hollowing | Presence of persistent temporal hollowing after the procedure | 24 months post-operative | |
Secondary | Neurological Assessment | Glasgow Coma Scale | 24 months post-operative | |
Secondary | Scale of brain injuries | Glasgow Outcome Scale Extended | 24 months post-operative | |
Secondary | Aesthetic assessment | Aesthetic assessment score | 24 months post-operative |
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