An observational study in Cranioplasty, Craniofacial Abnormalities and Craniofacial Injuries, sponsored by Stryker Craniomaxillofacial. Active, not recruiting at 13 sites in 6 countries. Open to participants aged 42 Months and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Stryker Craniomaxillofacial (part of Stryker) · 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 (up to 24-months) of study participants.
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.
22 studies on the registry are indexed under Craniofacial Abnormalities; 3 are open to participants now.
This study's planned enrollment of 99 is above the median of 77 across 12 observational studies indexed under Craniofacial Abnormalities.
Browse Craniofacial Abnormalities studies →Stryker Craniomaxillofacial is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with cranial and craniofacial defects requiring augmentation and/or restoration, e.g. following tumor resection, trauma, vascular conditions, or stroke requiring craniectomy, due to previously failed cranioplasty, or bone flap resorption.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a Stryker PEEK Customized Implant
Device: Stryker'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).
Infection Rate
Assessment of rate of infection associated with Stryker's PEEK Customized Implants.
Time frame: Up to 24 months post-operative
Incidence of device related serious adverse events (SAEs)
Incidence of device related SAEs up to 24 months post implantation
Time frame: Up to 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
Time frame: Up to 24 months post-operative
Rate of implant failure
Rate of implant failure leading to explantation
Time frame: Up to 24 months post-operative
Quality of life questionnaire
Outcome of Short Form health survey-12 (SF-12) quality of life questionnaire
Time frame: Up to 24 months post-operative
Length of hospitalisation
Time duration after surgery until hospital discharge
Time frame: 1 month
Persistent temporal hollowing
Presence of persistent temporal hollowing after the procedure
Time frame: Up to 24 months post-operative
Neurological Assessment
Glasgow Coma Scale
Time frame: Up to 24 months post-operative
Scale of brain injuries
Glasgow Outcome Scale Extended
Time frame: Up to 24 months post-operative
Aesthetic assessment
Aesthetic assessment score
Time frame: Up to 24 months post-operative
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Nov 2026, 45 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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