Custom plastic implants for skull and face defects under scrutiny in new study

NCT ID NCT05362370

Ongoing Disease control Sponsor: Stryker Craniomaxillofacial Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is checking how safe and effective Stryker's custom-made PEEK implants are for fixing bone and soft tissue problems in the skull and face. About 99 people who need these implants will be followed for up to 24 months after surgery. The main goal is to see how often infections or other serious problems happen.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: PEEK Customized Implant (a plastic-like medical device used to reconstruct bone defects in the skull and face)
What this could lead to: If successful, this could confirm that PEEK implants are a safe and effective option for repairing skull and facial bone defects, improving appearance and function.
What could go wrong: This is a post-market study, so the device is already approved. Risks include infection, implant failure, or serious side effects. The study is relatively small (99 people) and not randomized.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Craniofacial Abnormalities head injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CRANIOFACIAL ABNORMALITIES CRANIOFACIAL INJURIES CRANIOPLASTY

Contacts and locations

Locations

APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré

Paris, Paris France, 75010, France
CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1

Nantes, Pays de la Loire Region, 44093, France
Department of Neurological Surgery

New Brunswick, New Jersey, 07101-1709, United States
Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital

New York, New York, 10032, United States
Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240

Dortmund, North Rhine-Westphalia, 44145, Germany
Lewis Katz School of Medicine at Temple University, 3401 North Broad Street

Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA

Charleston, South Carolina, 29425, United States
Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust

London, London, SW7 2AZ, United Kingdom
Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9

Toulouse, Occitanie, TSA 40031 - 31059, France
Servicio de Neurocirugía Hospital Universitario La Paz.

Madrid, Madrid, 28046, Spain
St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263

Hamm, Hamm, 59073, Germany
University of Louisville 501 E. Broadway, Suite 210

Louisville, Kentucky, 40202, United States
Universitätsklinik für Neurochirurgie Auenbruggerplatz 29

Graz, 8036, Austria

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