Trials / Withdrawn
WithdrawnNCT01282645
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
A Retrospective Case Series to Evaluate the Long Term Outcome of the Use of Synthes Patient Specific Implants (PSI®) Made of Polyether Ether Ketone (PEEK) for the Treatment of Cranial Defects in Patients With a Mature Skeleton
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Synthes GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PSI in PEEK | A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
- First posted
- 2011-01-25
- Last updated
- 2013-03-22
Locations
30 sites across 15 countries: Austria, Belgium, Chile, Colombia, Costa Rica, Czechia, Denmark, Finland, France, Germany, Portugal, Singapore, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01282645. Inclusion in this directory is not an endorsement.