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 (S+Tibia component) Fixed Bearing Cruciate Retaining Knee System…
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. (PROMS)
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 (S+Tibia component) 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
(S+Tibia component) 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.
Bronovolaan 5
Den Haag 2597AX
NL
Bronovolaan 5
Den Haag 2597AX
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
General: All consecutive patients (*usual care*) are included to prevent
selection bias in the migration analysis.
Consent: Patient is capable of giving informed consent and expressing a
willingness to comply with this study
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).
Design
Recruitment
metc-ldd@lumc.nl
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 | NL66908.098.18 |