The objective of this research is to investigate in vivo by means of RSA the amount of wear of the insert very secure.Through frequently taken RSA measurements over a 3 year period, we might be able to predict the longevity of the XLPE insert.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Amount of wear of the insert in mm3 and mm/year (volumetric wear and linear
wear)
Secondary outcome
Knee function and pain by means of the Knee Society Score, The UCLA activity
score and the KOOS (Knee osteoarthritis and outcome score).
Background summary
Loosening of the knee prosthesis due to waer of the insert is a common and most
important reason for revision of the device.
Therefore continous research has and will be performed to improve the material
of the insert, with less waer and good tensile strength.
Cross-linked polyethylene (XLPE) has good waer resistance, and is used in Total
Hip Replacement with success.
But untill now no ersaerch in vivo have been performed concerning the wear of
XLPE compared to PE in total knee replacement.
Laboratory test have proven that the wear will 8 tiems less in XLPE compared to
PE (page 9).
Study objective
The objective of this research is to investigate in vivo by means of RSA the
amount of wear of the insert very secure.
Through frequently taken RSA measurements over a 3 year period, we might be
able to predict the longevity of the XLPE insert.
Study design
A prospective, single blind, randomized controlled trial. Envelops will be
opened during surgery not before the moment of implanting the insert.
Only the independent RSA analyst will be blind for the type of insert that has
been used.
Intervention
Intervention will be Total Knee Replacement.
Study burden and risks
No extra risk concerning the surgical intervanetion and rehabilitation.
Some extra burden to have the RSA graphs made and to complete the KOOS
questionnaire.
The extra x-ray burden for the RSA will even be below the standard norm for the
environmental x-ray burden in dayly live.
Oberneuhofstrasse 10d
6340 Baar
CH
Oberneuhofstrasse 10d
6340 Baar
CH
Listed location countries
Age
Inclusion criteria
Osteoarthrits;
Age 40-70;
ASA 1 or 2.
Exclusion criteria
Insufficient femoral or tibial bone stock
Body mass index > 35
history of major non-arthroscopic surgery to the study knee
active local or systemic infection
Grade 3 collateral ligament insufficiency
Knee Flexion < 90 degrees
Fixed knee flexion deformity of > 20 degrees
Varus or valgus deformity > 20 degrees
Rheumatoid arthritis, autoimmune disorder or immunosuppressive disorder.
Design
Recruitment
Medical products/devices used
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 | NL30780.056.10 |