CranioplastyNCT05362370
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
An observational study of Cranioplasty and Craniofacial Abnormalities, run by Stryker Craniomaxillofacial at 13 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 months and older
- Conditions the study is for
- Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries
- What is being tested?
- Stryker's PEEK Customized Implant
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 1 Feb 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
United States5 sites
Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA
Charleston, South Carolina, 29425
University of Louisville 501 E. Broadway, Suite 210
Louisville, Kentucky, 40202
Department of Neurological Surgery
New Brunswick, New Jersey, 07101-1709
Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital
New York, New York, 10032
Lewis Katz School of Medicine at Temple University, 3401 North Broad Street
Philadelphia, Pennsylvania, 19140
France3 sites
CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1
Nantes, Pays de la Loire Region, 44093
APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré
Paris, Paris France, 75010
Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9
Toulouse, Occitanie, TSA 40031 - 31059
Germany2 sites
Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240
Dortmund, North Rhine-Westphalia, 44145
St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263
Hamm, Hamm, 59073
Austria1 site
Universitätsklinik für Neurochirurgie Auenbruggerplatz 29
Graz, 8036
Spain1 site
Servicio de Neurocirugía Hospital Universitario La Paz.
Madrid, Madrid, 28046
United Kingdom1 site
Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust
London, London, SW7 2AZ
About this study
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.
Read the 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.
- Being tested
- Stryker's PEEK Customized Implant
- Medical subject headings
- Craniofacial Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryker's PEEK Customized ImplantDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants will receive a Stryker PEEK Customized Implant Receives: Device: Stryker's PEEK Customized Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rate
Assessment of rate of infection associated with Stryker's PEEK Customized Implants.
Measured: Up to 24 months post-operative
Secondary outcomes (9)
Incidence of device related serious adverse events (SAEs)
Incidence of device related SAEs up to 24 months post implantation
Measured: 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
Measured: Up to 24 months post-operative
Rate of implant failure
Rate of implant failure leading to explantation
Measured: Up to 24 months post-operative
Quality of life questionnaire
Outcome of Short Form health survey-12 (SF-12) quality of life questionnaire
Measured: Up to 24 months post-operative
Length of hospitalisation
Time duration after surgery until hospital discharge
Measured: 1 month
Persistent temporal hollowing
Presence of persistent temporal hollowing after the procedure
Measured: Up to 24 months post-operative
Neurological Assessment
Glasgow Coma Scale
Measured: Up to 24 months post-operative
Scale of brain injuries
Glasgow Outcome Scale Extended
Measured: Up to 24 months post-operative
Aesthetic assessment
Aesthetic assessment score
Measured: Up to 24 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Feb 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CranioplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Craniomaxillofacial
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qmed Consulting A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362370
- Sponsor's protocol ID
- CMF_2021_01
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
- ClinicalTrials.gov ID
- NCT05362370
- Acronym / sponsor ID
- CMF_2021_01
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Stryker CraniomaxillofacialIndustry (pharma, biotech, devices)
- Collaborators
- Qmed Consulting A/S
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Stryker's PEEK Customized ImplantParticipants will receive a Stryker PEEK Customized Implant |
Who may qualify
- Ages
- 42 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stryker's PEEK Customized ImplantThe 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). | Device | Cohort 1 |
Primary outcome
Infection Rate
Time frame: Up to 24 months post-operative
Assessment of rate of infection associated with Stryker's PEEK Customized Implants.
9 secondary outcomes
Incidence of device related serious adverse events (SAEs)
Time frame: Up to 24 months post-operative
Ability to place the Customized Implant during surgery leading to good aesthetic outcome
Time frame: Up to 24 months post-operative
Rate of implant failure
Time frame: Up to 24 months post-operative
Quality of life questionnaire
Time frame: Up to 24 months post-operative
Length of hospitalisation
Time frame: 1 month
Persistent temporal hollowing
Time frame: Up to 24 months post-operative
Neurological Assessment
Time frame: Up to 24 months post-operative
Scale of brain injuries
Time frame: Up to 24 months post-operative
Aesthetic assessment
Time frame: Up to 24 months post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cranioplasty and Craniofacial Abnormalities, run by Stryker Craniomaxillofacial at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, France, Germany, Austria, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection Rate (time frame: Up to 24 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.