The primary objective is to assess the in vivo wear of the two randomized polyethylene insert types N2Vac and X3 10 years after surgery. The secondary objective is to assess the migration and long-term survival of the Triathlon CS Peri-Apatite…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Total knee arthroplasty is commonly used to treat osteoarthritis. The Posterior
Stabilized (PS) knee prosthesis is the most implanted total knee prosthesis
design, but contribute to additional wear debris. Therefore, an alternative
bearing surface in total knee replacements was designed to attempt to reduce
wear by applying polyethylene in combination with the successful
characteristics of a PS knee resulting in the CR knee prosthesis. Ultra high
molecular weight polyethylene (UHMWPE) is nowadays the standard material used
for the articulating surface. X3-polyethylene is a new type of polyethylene
with improved mechanical properties and theoretically and in vitro improved
wear resistance over conventional and current generation cross-linked
polyethylene.
In a previous study (NL32489.098.10), we compared the wear obtained using
Roentgen Stereophotogrammatric Analysis (RSA) and clinical outcomes of the
conventional N2Vac with the X3 highly cross-linked polyethylene in a CS fixed
bearing total knee prosthesis (Triathlon Knee System: Stryker, Warsaw, USA)
during 5 year follow up. However, the time frame of 5 years seems too short to
show a significant difference in wear between the groups. Furthermore, we
hypothesize that stronger inserts (X3) might induce small partical wear
resulting in loosening of the prosthesis.
Study objective
The primary objective is to assess the in vivo wear of the two randomized
polyethylene insert types N2Vac and X3 10 years after surgery. The secondary
objective is to assess the migration and long-term survival of the Triathlon CS
Peri-Apatite coated tibial component and to assess the clinical scores and
radiographic aspects 10 years after surgery.
Study design
This study is a cohort study, describing the 10 year-follow up after
implantation of the CS fixed bearing total knee prosthesis in combination with
a N2Vac or X3 insert, which was part of a prospective randomized single center
study (NL32489.098.10, METC 10-068). Radiostereometric analysis (RSA) will be
used to determine the wear of both inserts.
Study burden and risks
There are no benefits for patients in this study. RSA radiographs will be made
once and patients will be asked to visit once the outpatient clinic and fill in
questionnaires.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77360.058.21 |