Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
- Conditions
- CranioplastyCraniofacial AbnormalitiesCraniofacial Injuries
- Interventions
- Device: Stryker's PEEK Customized Implant
- Registration Number
- NCT05362370
- Lead Sponsor
- Stryker Craniomaxillofacial
- 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 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.
- 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 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 craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH). Infection of implants is one of the common risks associated with this type of surgery. This PMCF study will investigate infection rate as the primary safety endpoint. These data will be collected in a real world setting, where all treatment is per routine clinical practice. The study is designed as a prospective, multi-center trial at participating institutions in the United States and in Europe. Up to 110 study participants will be enrolled in this PMCF. Stryker's PEEK Customized Implants are intended to stay implanted permanently. Therefore, study participants will be followed for 24 months after implantation of the devices to allow evaluation of long-term safety and performance of the products.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Stryker's PEEK Customized Implant Participants will receive a Stryker PEEK Customized Implant
- Primary Outcome Measures
Name Time Method Infection Rate 24 months post-operative Assessment of rate of infection associated with Stryker's PEEK Customized Implants.
- Secondary Outcome Measures
Name Time Method Neurological Assessment 24 months post-operative Glasgow Coma Scale
Length of hospitalisation Up to 1 month Time duration after surgery until hospital discharge
Persistent temporal hollowing 24 months post-operative Presence of persistent temporal hollowing after the procedure
Ability to place the Customized Implant during surgery leading to good aesthetic outcome 24 months post-operative Assessment of success of placement by the surgeon as determined by the ability to close the defect effectively, even with modification of implant
Quality of life questionnaire 24 months post-operative Outcome of Short Form health survey-12 (SF-12) quality of life questionnaire
Scale of brain injuries 24 months post-operative Glasgow Outcome Scale Extended
Aesthetic assessment 24 months post-operative Aesthetic assessment score
Rate of implant failure 24 months post-operative Rate of implant failure leading to explantation
Incidence of device related serious adverse events (SAEs) 24 months post-operative Incidence of device related SAEs up to 24 months post implantation
Trial Locations
- Locations (9)
Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240
🇩🇪Dortmund, Nordrhein-Westfalen, Germany
Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital
🇺🇸New York, New York, United States
University of Louisville 501 E. Broadway, Suite 210
🇺🇸Louisville, Kentucky, United States
Universitätsklinik für Neurochirurgie Auenbruggerplatz 29
🇦🇹Graz, Austria
Lewis Katz School of Medicine at Temple University, 3401 North Broad Street
🇺🇸Philadelphia, Pennsylvania, United States
Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9
🇫🇷Toulouse, Occitanie, France
St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263
🇩🇪Hamm, Germany
Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Servicio de Neurocirugía Hospital Universitario La Paz.
🇪🇸Madrid, Spain