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

Craniofacial Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05362370
• Other study ID #: CMF_2021_01
• Status: Enrolling by invitation
• Start date: February 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Stryker Craniomaxillofacial
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The study is designed as a prospective, multi-center trial with a long-term follow-up (24 months) of study participants.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110
• Est. completion date: December 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Craniofacial Abnormalities
• Craniofacial Injuries
• Cranioplasty

Intervention

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).

Locations

Country	Name	City	State
Austria	Universitätsklinik für Neurochirurgie Auenbruggerplatz 29	Graz
France	Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9	Toulouse	Occitanie
Germany	Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240	Dortmund	Nordrhein-Westfalen
Germany	St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263	Hamm
Spain	Servicio de Neurocirugía Hospital Universitario La Paz.	Madrid
United Kingdom	Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust	London
United States	University of Louisville 501 E. Broadway, Suite 210	Louisville	Kentucky
United States	Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital	New York	New York
United States	Lewis Katz School of Medicine at Temple University, 3401 North Broad Street	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Stryker Craniomaxillofacial	Qmed Consulting A/S

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection Rate	Assessment of rate of infection associated with Stryker's PEEK Customized Implants.	24 months post-operative
Secondary	Incidence of device related serious adverse events (SAEs)	Incidence of device related SAEs up to 24 months post implantation	24 months post-operative
Secondary	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
Secondary	Rate of implant failure	Rate of implant failure leading to explantation	24 months post-operative
Secondary	Quality of life questionnaire	Outcome of Short Form health survey-12 (SF-12) quality of life questionnaire	24 months post-operative
Secondary	Length of hospitalisation	Time duration after surgery until hospital discharge	Up to 1 month
Secondary	Persistent temporal hollowing	Presence of persistent temporal hollowing after the procedure	24 months post-operative
Secondary	Neurological Assessment	Glasgow Coma Scale	24 months post-operative
Secondary	Scale of brain injuries	Glasgow Outcome Scale Extended	24 months post-operative
Secondary	Aesthetic assessment	Aesthetic assessment score	24 months post-operative