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

RecruitingOBSERVATIONAL
Enrollment

110

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

September 30, 2027

Study Completion Date

December 30, 2027

Conditions
CranioplastyCraniofacial AbnormalitiesCraniofacial Injuries
Interventions
DEVICE

Stryker's PEEK Customized Implant

The PEEK Customized Implants will be used in this patient cohort for augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

Trial Locations (13)

8036

RECRUITING

Universitätsklinik für Neurochirurgie Auenbruggerplatz 29, Graz

10032

RECRUITING

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

19140

ENROLLING_BY_INVITATION

Lewis Katz School of Medicine at Temple University, 3401 North Broad Street, Philadelphia

28046

RECRUITING

Servicio de Neurocirugía Hospital Universitario La Paz., Madrid

29425

RECRUITING

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

40202

ENROLLING_BY_INVITATION

University of Louisville 501 E. Broadway, Suite 210, Louisville

44093

ENROLLING_BY_INVITATION

CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1, Nantes

44145

RECRUITING

Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240, Dortmund

75010

RECRUITING

APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré, Paris

07101-1709

ENROLLING_BY_INVITATION

Department of Neurological Surgery, New Brunswick

TSA 40031 - 31059

RECRUITING

Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9, Toulouse

Hamm

RECRUITING

"St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 , 1263"

London

RECRUITING

"Neurosurgery, Emergency and Major Trauma (NET) Research , Division of Medicine

All Listed Sponsors
collaborator

Qmed Consulting A/S

INDUSTRY

lead

Stryker Craniomaxillofacial

INDUSTRY