The primary aim of this study is to accurately compare the mid and long-term migration of two uncemented total knee prostheses. The secondary objectives of this study are to evaluate whether inducible displacement can be used as a parameter to…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Migration measured with RSA
Secondary outcome
- Inducible displacement measured with RSA.
- Patient-reported satisfaction is measured by questionnaires.
- Clinical and radiographic outcomes are measured by physical examination and
RSA radiographs.
Background summary
Every year 1.5 million knee prostheses are implanted worldwide in patients
whose knee is severely damaged by osteoarthritis, rheumatism or trauma,
resulting in severe pain and loss of function. By 2030, these numbers will have
increased sixfold to 7.5 million cases annually due to the aging and increasing
population (Kurd et al. 2007). In addition, it is seen that increasingly
younger and heavier patients need a knee prosthesis, while they are often still
active and, due to their younger age, have to use their prosthesis for a longer
period of time. A successfully placed prosthesis reduces pain, restores the
function of the joint and functions for at least 10 years, but preferably
longer. It is therefore important that new prostheses that come onto the market
are improved compared to their predecessors and that these prostheses can be
used for a longer period of time.
Study objective
The primary aim of this study is to accurately compare the mid and long-term
migration of two uncemented total knee prostheses. The secondary objectives of
this study are to evaluate whether inducible displacement can be used as a
parameter to detect implant loosening, and to compare inducible displacement,
clinical and radiological outcomes, and patient-reported outcomes after a
follow-up of 5 and 10 years of two uncemented knee prostheses: the cementless
ATTUNE rotary platform knee prosthesis and the cementless LCS rotary platform
knee prosthesis. Both are supplied by DePuy Synthes, Warsaw, Indiana, USA.
Study design
This study is a follow-up to the initial study set up in 2017. (NL58911.058.16)
Patients now know what kind of prosthesis they received at the time. Therefore,
this study is no longer blind, but a randomized study between the LCS and
ATTUNE knee prosthesis.
Study burden and risks
Patients participating in this study will not benefit directly, but the results
of this study will improve the understanding of the fixation and performance of
cementless prosthesis. This information is very useful in optimizing knee
prosthesis designs based on better fixation and better long-term outcomes.
Spaarnepoort 1
Hoofddorp 2134TM
NL
Spaarnepoort 1
Hoofddorp 2134TM
NL
Listed location countries
Age
Inclusion criteria
- All patients that participated in the initial study (NL58911.058.16)
- Patient that are capable of giving informed consent and expressing a
willingness to comply with the study.
Exclusion criteria
- The patient underwent a major revision TKR (exchange of the tibial or femoral
component).
- The patient is unable or unwilling to sign the informed consent specific to
this study.
Design
Recruitment
Medical products/devices used
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 | NL82000.058.22 |