Polyethylene Wear of the N2Vac and X3 insert in the Triathlon Total Knee Prosthesis: 10 years follow up of a prospective Randomized Single Centre RSA study

Completed

• Conditions: degenerative joint disease; osteoarthritis; 10005944

• Registration Number: NL-OMON50837
• Lead Sponsor: Reinier Haga Orthopedisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• 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- The patient was withdrawn from the previous study;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 invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the in-vivo wear in mm of the N2Vac insert compared<br /><br>to the wear of the X3 insert, 10 years after surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are migration and long-term survival of the Triathlon CS<br /><br>Peri-Apatite coated tibial component, clinical scores and radiographic<br /><br>aspects.Clinical scores are expressed by the scores of the following<br /><br>questionnaires: the Knee Society Score (KSS), EQ-5D-3L, SF-36 and<br /><br>Lower-Extremities Activity Scale (LEAS). </p><br>