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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Craniofacial Abnormalities; Cranioplasty; Craniofacial Injuries
• Intervention / Treatment: Device: Stryker's PEEK Customized Implant

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 24 months after implantation of the devices to allow evaluation of long-term safety and performance of the products.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Universitätsklinik für Neurochirurgie Auenbruggerplatz 29
• France
  • Occitanie
    • Toulouse, Occitanie, France, TSA 40031 - 31059
      • Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9
• Germany
  • Hamm, Germany, 59073
    • St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263
  • Nordrhein-Westfalen
    • Dortmund, Nordrhein-Westfalen, Germany, 44145
      • Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240
• Spain
  • Madrid, Spain, 28046
    • Servicio de Neurocirugía Hospital Universitario La Paz.
• United Kingdom
  • London, United Kingdom, SW7 2AZ
    • Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust
• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville 501 E. Broadway, Suite 210
  • New York
    • New York, New York, United States, 10032
      • Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Lewis Katz School of Medicine at Temple University, 3401 North Broad Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stryker Craniomaxillofacial
• Collaborators: Qmed Consulting A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Craniofacial Abnormalities
• Other Study ID Numbers: CMF_2021_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No