RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-01
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05362370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:42 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ilka Meinert, Ph.D
CONTACT
+49 170 384 5636
Ilka.meinert@stryker.com
Stephanie John, Ph.D
CONTACT
+41 79 651 3268
sjo@qmed-consulting.com

Study Locations (Sites)

University of Louisville 501 E. Broadway, Suite 210
Louisville, Kentucky, 40202
United States
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
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

Collaborators and Investigators

Sponsor: Stryker Craniomaxillofacial

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2027-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cranioplasty
  • Craniofacial Abnormalities
  • Craniofacial Injuries