Craniofacial Abnormalities, Craniofacial Injuries, Cranioplasty
Conditions
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 (up to 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 up to 24-months after implantation of the devices to allow evaluation of long-term safety and performance of the products.
Interventions
DEVICEStryker's PEEK Customized Implant
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).
Sponsors
Stryker Craniomaxillofacial
Qmed Consulting A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
42 Months to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection Rate | Up to 24 months post-operative | Assessment of rate of infection associated with Stryker's PEEK Customized Implants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device related serious adverse events (SAEs) | Up to 24 months post-operative | Incidence of device related SAEs up to 24 months post implantation |
| Ability to place the Customized Implant during surgery leading to good aesthetic outcome | Up to 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 |
| Rate of implant failure | Up to 24 months post-operative | Rate of implant failure leading to explantation |
| Quality of life questionnaire | Up to 24 months post-operative | Outcome of Short Form health survey-12 (SF-12) quality of life questionnaire |
| Length of hospitalisation | 1 month | Time duration after surgery until hospital discharge |
| Persistent temporal hollowing | Up to 24 months post-operative | Presence of persistent temporal hollowing after the procedure |
| Neurological Assessment | Up to 24 months post-operative | Glasgow Coma Scale |
| Scale of brain injuries | Up to 24 months post-operative | Glasgow Outcome Scale Extended |
| Aesthetic assessment | Up to 24 months post-operative | Aesthetic assessment score |
Countries
Austria, France, Germany, Spain, United Kingdom, United States
Outcome results
None listed