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

NCT05362370 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2025-10-17

No results posted yet for this study

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.

Conditions

  • Cranioplasty
  • Craniofacial Abnormalities
  • Craniofacial 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).

Sponsors & Collaborators

  • Qmed Consulting A/S

    collaborator INDUSTRY

  • Stryker Craniomaxillofacial

    lead INDUSTRY

Eligibility

Min Age
42 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2027-09-30
Completion
2027-12-30
FDA Device
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05362370 on ClinicalTrials.gov