No registrations found.
ID
Source
Health condition
Knee replacement for painful primary or secondary osteoarthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
RSA migration during the first 5 years of follow-up.
Secondary outcome
Function, Knee Society Score, Complications.
Background summary
Before widespread introduction to the market, new prosthesis designs or related developments, the intitial performance should be evaluated using Roentgen Stereophotogrammetric Analysis (RSA). This highly accurate measurement technique determines the initial migration, and thus fixation, of prostheses, which has been shown to be predictive of long-term survivorship. This study is a 4-arm randomized controlled trial which compares the clinical outcome and migration (RSA) of a conventional NexGen Total Knee Posthesis (TKP) with the newly introduced high-flex NexGen TKP, both designs have either a mobile or fixed bearing.
Study objective
Two year migration is comparable between all 4 groups.
Study design
3, 6 and 12 months, annually thereafter.
Intervention
Knee replacement with either a high-flex or conventional NexGen total knee prosthesis with either a fixed or mobile bearing.
Orthopedic surgery<br>
P.O. box 9600
M.J. Nieuwenhuijse
Leiden 2300 RC
The Netherlands
+31 (0)71 5263795
M.J.Nieuwenhuijse@lumc.nl
Orthopedic surgery<br>
P.O. box 9600
M.J. Nieuwenhuijse
Leiden 2300 RC
The Netherlands
+31 (0)71 5263795
M.J.Nieuwenhuijse@lumc.nl
Inclusion criteria
All suitable candidates for a Total Knee Replacement who are willing to participate in the study and follow-up.
Exclusion criteria
1. Refusal to participate;
2. Other indications than osteoarhtritis as a reason for knee replacement.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL3143 |
| NTR-old | NTR3287 |
| Other | METC LUMC : p04.288 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |