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Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years

NCT01282645 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2013-03-22

No results posted yet for this study

Summary

The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.

Conditions

  • E04.525.190
  • Craniotomy
  • Craniectomy

Interventions

DEVICE

PSI in PEEK

A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect

Sponsors & Collaborators

  • Synthes GmbH

    lead INDUSTRY

Principal Investigators

  • Frédéric Lauwers, MD · Centre Hospitalier Universitaire de Toulouse, Toulouse, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Austria
  • Belgium
  • Chile
  • Colombia
  • Costa Rica
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Portugal
  • Singapore
  • Spain
  • Switzerland
  • 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 NCT01282645 on ClinicalTrials.gov