Trials / Terminated
TerminatedNCT02831595
Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- Permedica spa · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions. Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients. The aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2019-01-01
- Completion
- 2019-01-01
- First posted
- 2016-07-13
- Last updated
- 2019-10-23
Source: ClinicalTrials.gov record NCT02831595. Inclusion in this directory is not an endorsement.