Validation and implementation of the Comforthod-Knee System for accurate diagnosis of mechanical loosening and movement of a metal implant in the human body.
Completed
- Conditions
- 10023213Knie protheseaseptic looseningmechanical loosening
- Registration Number
- NL-OMON52996
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
-Patients diagnosed with aseptic loosening of the knee prosthesis and that are
scheduled for revision surgery.
- Patients with a TKA who are asymptomatic and have no complaints oftheir knee
prosthesis.
- Patients capable of giving informed consent and are willing to do this extra
examination
Exclusion Criteria
- Patients with another cause for revison surgery besides aseptic loosening.
- Patients who are unable or unwilling to sign the informed consent for this
study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method