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

NCT ID NCT05362370

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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