RECRUITING

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

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Cranioplasty
Intervention / Treatment

-

Contacts and Locations

Louisville

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

New Brunswick

Department of Neurological Surgery, New Brunswick, New Jersey, United States, 07101-1709

New York

Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital, New York, New York, United States, 10032

Philadelphia

Lewis Katz School of Medicine at Temple University, 3401 North Broad Street, Philadelphia, Pennsylvania, United States, 19140

Charleston

Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA, Charleston, South Carolina, United States, 29425

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    42 Months to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Stryker Craniomaxillofacial,

    Study Record Dates

    2027-12-30