Polyethylene wear study on the Triathlon Total Knee Prosthesis: a 10 years follow up RSA study
Recruiting
- Conditions
- Osteoarthritis
- Registration Number
- NL-OMON21734
- Lead Sponsor
- Stryker
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 87
Inclusion Criteria
Received a Total Knee Joint prosthesis between September 2011 and May 2014;
- Participated in the study assessing the mid-term wear of the N2Vac or X3 insert;
- Sign informed consent of the proposed study.
Exclusion Criteria
- The patient was withdrawn from the previous study;
- Revision/Removal of study device;
- Patient withdrawal on patients own request;
- Lost to Follow-Up;
- Death of the patient;
- The patient is unable or unwilling to sign the Informed Consent specific to this study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In-vivo wear
- Secondary Outcome Measures
Name Time Method Migration (translation and rotation in 3 directions)<br>Long-term survival<br>Knee Society Score (KSS)<br>EQ-5D-3L<br>SF-36<br>Lower-Extremities Activity Scale (LEAS)