Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness

Conditions
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Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries

Intervention / Treatment
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* Device: Stryker's PEEK Customized Implant


Participation Criteria
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Eligibility Criteria
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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. Subject who has an expected survival rate of less than 2 years, in the opinion of the investigator who takes consent.

Ages Eligible for Study
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Minimum Age: 42 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants will receive a Stryker PEEK Customized Implant | Device: Stryker's PEEK Customized Implant<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Rate | Assessment of rate of infection associated with Stryker's PEEK Customized Implants. | 24 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device related serious adverse events (SAEs) | Incidence of device related SAEs up to 24 months post implantation | 24 months post-operative | 
| 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 | 
| Rate of implant failure | Rate of implant failure leading to explantation | 24 months post-operative | 
| Quality of life questionnaire | Outcome of Short Form health survey-12 (SF-12) quality of life questionnaire | 24 months post-operative | 
| Length of hospitalisation | Time duration after surgery until hospital discharge | Up to 1 month | 
| Persistent temporal hollowing | Presence of persistent temporal hollowing after the procedure | 24 months post-operative | 
| Neurological Assessment | Glasgow Coma Scale | 24 months post-operative | 
| Scale of brain injuries | Glasgow Outcome Scale Extended | 24 months post-operative | 
| Aesthetic assessment | Aesthetic assessment score | 24 months post-operative |