Clinical trial NCT05362370: Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
Official title: Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cranioplasty
Craniofacial Abnormalities
Craniofacial Injuries
Lead sponsor: Stryker Craniomaxillofacial
Sponsor class: INDUSTRY
Collaborators: name: Qmed Consulting A/S
First posted: 2022-05-05
Enrollment: 110
Sex: ALL
Minimum age (years): 42
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Infection Rate
timeFrame: 24 months post-operative
Secondary outcomes:
measure: Incidence of device related serious adverse events (SAEs)
timeFrame: 24 months post-operative
measure: Ability to place the Customized Implant during surgery leading to good aesthetic outcome
timeFrame: 24 months post-operative
measure: Rate of implant failure
timeFrame: 24 months post-operative
measure: Quality of life questionnaire
timeFrame: 24 months post-operative
measure: Length of hospitalisation
timeFrame: Up to 1 month
measure: Persistent temporal hollowing
timeFrame: 24 months post-operative
measure: Neurological Assessment
timeFrame: 24 months post-operative
measure: Scale of brain injuries
timeFrame: 24 months post-operative
measure: Aesthetic assessment
timeFrame: 24 months post-operative
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville 501 E. Broadway, Suite 210
state: Kentucky
city: New Brunswick
country: United States
facility: Department of Neurological Surgery
state: New Jersey
city: New York
country: United States
facility: Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital
state: New York
city: Philadelphia
country: United States
facility: Lewis Katz School of Medicine at Temple University, 3401 North Broad Street
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA
state: South Carolina
city: Graz
country: Austria
facility: Universitätsklinik für Neurochirurgie Auenbruggerplatz 29
city: Toulouse
country: France
facility: Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9
state: Occitanie
city: Paris
country: France
facility: APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré
state: Paris France
city: Nantes
country: France
facility: CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1
state: Pays de la Loire
city: Dortmund
country: Germany
facility: Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240
state: Nordrhein-Westfalen
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263
city: Madrid
country: Spain
facility: Servicio de Neurocirugía Hospital Universitario La Paz.
city: London
country: United Kingdom
facility: Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust
Study officials:
References: