NCT05362370

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Stryker Craniomaxillofacial · Industry
• Sex: All
• Age: 42 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Stryker's PEEK Customized Implants are patient-specific implants based on CT-data of the individual patient and input of the surgeon. The implants are fabricated from Polyetheretherketone (PEEK) and intended to be used to fill bony voids in the cranial and craniofacial region (e.g. cranium, orbital rim, zygoma, and adjacent bone). This observational post-market clinical follow-up (PMCF) is designed to confirm the safety, performance and clinical benefit of Stryker's PEEK Customized Implants 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). Infection of implants is one of the common risks associated with this type of surgery. This PMCF study will investigate infection rate as the primary safety endpoint. These data will be collected in a real world setting, where all treatment is per routine clinical practice. The study is designed as a prospective, multi-center trial at participating institutions in the United States and in Europe. Up to 110 study participants will be enrolled in this PMCF. Stryker's PEEK Customized Implants are intended to stay implanted permanently. Therefore, study participants will be followed for 24 months after implantation of the devices to allow evaluation of long-term safety and performance of the products.

Conditions

• Cranioplasty
• Craniofacial Abnormalities
• Craniofacial Injuries

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-02-01
• Primary completion: 2027-09-30
• Completion: 2027-12-30
• First posted: 2022-05-05
• Last updated: 2025-10-20

Locations

13 sites across 6 countries: United States, Austria, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated device study