The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented ATTUNE Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Migration, measured by means of RSA.
Secondary outcome
Patient Reported Outcome Measures by means of questionaires.
Background summary
Every year, 1.5 million knee prostheses are implanted worldwide in patients
whose joints have been severely affected by osteoarthritis, rheumatoid
arthritis, or trauma, causing intense pain and loss of function. By 2030 these
numbers will have increased six-fold to 7.5 million cases annually,
because of our aging and increasingly obese society (Kurtz et al., 2007).
Successful joint replacement surgery provides pain reduction,
restores joint function, and will last 10 years at least.
Study objective
The objective of this study is to accurately assess and compare migration,
clinical and radiological outcome and patient reported outcomes of two
TKR prostheses: the Cemented ATTUNE Fixed Bearing Cruciate Retaining
Knee System and the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee
System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary objective of
this study is to compare the magnitude
and pattern of migration of the prostheses (Femoral and Tibial component).
Study design
This study is designed as a single-blind, randomized trial between
the ATTUNE Knee System and PFC Sigma Knee System. 32 patients with the
ATTUNE Knee System and 32 patients with PFC Sigma Knee System will be included
in this study.
Intervention
Total Knee replacement Surgery
Study burden and risks
Potential risks are risks associated with normal total knee
replacements such as infection, migration, bone loss, pain, loosening of
components, thromboembolic complications and risks involving anaesthesia. While
the patients participating in this study may not directly derive any immediate
benefits, the results of the study should improve the understanding of the
fixation and functioning of the prosthesis. This information will be
extremely useful in optimising knee implant designs based on better
fixation and improved long-term results.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Age: 21- 90 years Indications: Patient is diagnosed with osteoarthritis or
rheumatoid arthritis and requiring primary knee arthroplasty
Exclusion criteria
The patient has an a-priori risk for a posterior-stabilized total knee
arthroplasty.
Insufficiency of the posterior cruciate ligament (PCL)
Status after patellectomy
In case flexion is less than 90 degrees
When it is expected that the tibia cut during surgery will compromise the
attachment of the PCL (because of bony defects)
The patient is unable or unwilling to sign the Informed Consent specific to
this study The patient does not understand the Dutch or English language good
enough to participate Patients indicated for revision arthroplasty When there
are not enough markers visible in the baseline RSA photograph and it will not
improve by placing the patient in another position, the patient will
be excluded from the study (secondary exclusion criteria). s="fieldla
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 | NL48357.058.14 |