Polyethylene wear study on the Triathlon Total Knee Prosthesis: a 10 years follow up 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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21734

Enrollment

Registered

2021-06-30

Start date

2021-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Osteoarthritis

Interventions

1. N2Vac inlay 2. X3 inlay Both combined with a CS fixed bearing total knee prosthesis (Triathlon Knee System: Stryker, Warsaw, USA)

Eligibility

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Exclusion criteria: - The patient was withdrawn from the previous study; - Revision/Removal of study device; - Patient withdrawal on patients own request; - Lost to Follow-Up; - Death of the patient; - The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

Secondary

Measure	Time frame
Migration (translation and rotation in 3 directions) Long-term survival Knee Society Score (KSS) EQ-5D-3L SF-36 Lower-Extremities Activity Scale (LEAS)	—

Contacts

Public ContactOnderzoek RHOC

Reinier Haga Orthopedisch Centrum

Onderzoek@rhoc.nl+31(0)79 206 5595

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)