RecruitingNCT05362370

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

Sponsor

Stryker Craniomaxillofacial

Enrollment

110 participants

Start Date

Feb 1, 2023

Study Type

OBSERVATIONAL

Conditions

Cranioplasty Craniofacial Injuries Craniofacial Abnormalities

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.

Eligibility

Min Age: 42 Months

Plain Language Summary

Simplified for easier understanding

This study is following patients who receive a custom-made PEEK (a medical-grade polymer) skull or craniofacial implant to evaluate how well it works over time. PEEK implants are used to repair bone defects in the skull or face following injury, surgery, or disease. You may be eligible if... - You need a PEEK customized implant as part of your normal care - You are at least 3.5 years old (USA) or at least 12 years old (Europe) - You are an adult who can give consent, or you have a parent or legal guardian who can consent on your behalf You may NOT be eligible if... - You have an active local or systemic infection - You have a known allergy to plastics or polymers, or sensitivity to foreign bodies - Your bone quality is compromised due to poor blood supply, infection, or prior implants - You have a mental or neuromuscular disorder that would put the implant at risk - You are knowingly pregnant or nursing - You are currently participating in another cranioplasty clinical trial - Your expected survival is less than 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEStryker'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(13)

University of Louisville 501 E. Broadway, Suite 210

Louisville, Kentucky, United States

Department of Neurological Surgery

New Brunswick, New Jersey, 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, United States

Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA

Charleston, South Carolina, United States

Universitätsklinik für Neurochirurgie Auenbruggerplatz 29

Graz, Austria

Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9

Toulouse, Occitanie, France

APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré

Paris, Paris France, France

CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1

Nantes, Pays de la Loire Region, France

St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263

Hamm, Hamm, Germany

Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240

Dortmund, North Rhine-Westphalia, Germany

Servicio de Neurocirugía Hospital Universitario La Paz.

Madrid, Madrid, Spain

Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust

London, London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05362370

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