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

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 - Triathlon Total Knee Prosthesis RSA 10 years follow up

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50837

Enrollment

Registered

2021-07-08

Start date

2021-10-08

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

degenerative joint disease osteoarthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - The patient was withdrawn from the previous study; - Revision/Removal of study device; - Patient withdrawal on patients own request; - Lost to Follow-Up; - Death of the patient; - The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.

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the in-vivo wear in mm of the N2Vac insert compared to the wear of the X3 insert, 10 years after surgery.	—

Secondary

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

Countries

Netherlands

Outcome results