Active not recruitingOBSERVATIONAL

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

This study is checking how safe and effective a special type of implant from Stryker is. These implants are custom-made for people needing to correct or rebuild bones in their skull or face, for example after an injury or because of a birth condition. The implants are made from a strong plastic called PEEK. Researchers want to make sure the implants work well and don't cause problems for patients in the long run. We're observing about 110 people in the US and Europe who receive these implants as part of their usual care. We'll be keeping an eye on them for up to two years after their surgery to see how they get on, especially looking out for any infections.

At a glance

Status

Active not recruiting

Sponsor

Stryker Craniomaxillofacial

Enrolment target

Start

01 Feb 2023

Estimated completion

30 Jun 2027

Cranioplasty Craniofacial Abnormalities Craniofacial Injuries

What is this study about?

This study is all about a special type of implant used to help people who need to fix or rebuild parts of their skull or face. This might be because of an injury, a birth condition, or another problem with the bones in these areas. The implants are unique because they are custom-made for each patient, using scans of their own head. They are also made from a strong, medical-grade plastic called PEEK.

The main goal of this study is to make sure these Stryker PEEK implants are safe and work well for patients. Doctors want to see how effective they are at correcting bone problems and whether they help patients feel better and improve their appearance or bone structure. It's a bit like checking on a new product after it's been used for a while in real life.

Researchers will be carefully watching people who receive these implants as part of their normal treatment. They'll follow these patients for up to two years to see how the implants perform over time. A key thing they'll be looking at is whether patients develop any infections, which can sometimes be a risk with any implant surgery. This helps doctors confirm the implants are a good, long-lasting solution.

Key takeaways

This study evaluates Stryker's custom PEEK implants for skull and facial bone correction.
The implants are specifically designed for individual patients.
Researchers are tracking safety and effectiveness in real-world patients for up to two years.
Your medical treatment won't change; the study just collects information.
A key focus is monitoring for potential risks like infection after surgery.

Who may be eligible?

To be considered for this study, you would typically be someone who needs a PEEK custom implant as part of your regular medical treatment. In Europe, you need to be at least 12 years old, and in the USA, at least 3 and a half years old. Adults must be able to agree to take part themselves, or if you're under 18 or can't agree yourself, a parent or legal guardian can give permission for you. For children in France, both parents usually need to sign.

There are some reasons why you might not be able to join. For example, if you have an active infection somewhere in your body, or if you're allergic to plastics or certain materials. If your bones are weak or unhealthy, or if you have a condition that might make the implant unstable, you might not be suitable. Pregnant or breastfeeding women usually can't take part, and neither can people who are already in another study looking at similar head or face bone surgeries. Also, if a doctor thinks your life expectancy is less than two years, you might not be included.

Quick self-check

Do you need an implant to fix bone in your head or face?
Are you 12 years old or older (if in Europe), or 3.5 years or older (if in the USA)?
Do you not have an active infection or allergies to plastics?
Are you able to agree to take part, or do you have a parent/guardian who can?
Are you not pregnant or breastfeeding?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, you won't be given any new or experimental treatments. All your care, including the surgery to fit the Stryker PEEK implant, will be exactly what your doctor would normally recommend for your condition. The study simply involves your doctors collecting information about how you recover and how your implant performs after it's been fitted.

This means you'll have regular check-ups and assessments, just as you would usually have after this type of surgery. The study team will gather details about your health and the implant's progress during these routine appointments. In total, doctors will follow your progress for up to two years after your implant surgery to see how you're doing in the long term.

Potential risks and benefits

Taking part in this study could help doctors learn more about how well these custom implants work, potentially benefiting future patients with similar conditions. There's no extra risk to you from being in the study, as all your treatment will be your standard medical care. However, any surgery, including implant surgery, carries some risks like infection or problems with how the implant settles. The study will specifically monitor for these common risks. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (13)

University of Louisville 501 E. Broadway, Suite 210
Louisville, United States
Department of Neurological Surgery
New Brunswick, United States
Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital
New York, United States
Lewis Katz School of Medicine at Temple University, 3401 North Broad Street
Philadelphia, United States
Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA
Charleston, United States
Universitätsklinik für Neurochirurgie Auenbruggerplatz 29
Graz, Austria
Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9
Toulouse, France
APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré
Paris, France
CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1
Nantes, France
St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263
Hamm, Germany
Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240
Dortmund, Germany
Servicio de Neurocirugía Hospital Universitario La Paz.
Madrid, Spain

+1 more sites — see the official record for the full list.

Common questions

What is a PEEK implant?

It's a custom-made implant, shaped specifically for your skull or face, and made from a strong, special plastic called PEEK.

What kind of problems does this implant help with?

It helps fix or rebuild bones in your head or face, for example, after injury, or to correct certain conditions or deformities.

Will I get special treatment in this study?

No, you will receive the same care and treatment your doctor would normally provide for your condition. The study just gathers information about your progress.

How long will I be followed in the study?

You will be followed for up to two years after your implant surgery to see how you are doing over time.

What is the main thing the study is looking for?

The study is mainly checking how safe the implant is and how well it works, especially looking out for any issues like infection.