Stryker PEEK PMCF
Research type
Research Study
Full title
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness.
IRAS ID
313998
Contact name
Mark Wilson
Contact email
Sponsor organisation
Stryker European Operations Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
The aim is to confirm the safety, performance and effectiveness of Stryker’s PEEK customiesd implants.
The PEEK Customised cranial implants Kit is indicated for the 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) in patients 12 years of age and older.
Participants will have cranial and craniofacial defects requiring augmentation and restoration, e.g. following tumour resection, trauma, vascular conditions, or stroke requiring craniectomy, due to previously failed cranioplasty, or bone flap resorption.
Up to 15 sites will be included in Austria, France, Germany, Spain, UK and USA.
Approximately 110 subjects will be enrolled in the PMCF over a fifteen month period. They will be followed up for two years after the procedure.
REC name
London - Bromley Research Ethics Committee
REC reference
22/LO/0559
Date of REC Opinion
26 Sep 2022
REC opinion
Further Information Favourable Opinion