Musculoskeletal Diseases Clinical Trial
Official title:
A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE™ Fixed Bearing Cruciate Retaining Knee System With the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System
The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent
clinical track record, good survival rates (98% 10 years survival in patients aged < 55
years)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at
two years follow-up)(von et al., 2009).
The ATTUNE™ Knee by DePuy Synthes is an advancement in knee replacement options. It is
designed to provide better range of motion and address the unstable feeling some patients
experience during everyday activities, such as stair descent and bending. To date (March
2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch and
positive feedback was received regarding patient recovery, stability and motion.
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). The secondary objective of this study is to
compare clinical and radiological outcome of the prostheses and PROMS. The tertiary objective
of this study is to compare clinical and radiological outcome and PROMS of the prostheses
with migration data.
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.
The study population will consist of patients with symptomatic osteoarthritis of the knee
scheduled for TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The
Hague, The Netherlands. Annually 300 TKA procedures are performed in this department, of
which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other
indications. We anticipate that inclusion can be accomplished within a 1 year period and that
the total study duration is 3 years.
Main study parameters/endpoints are:
- Migration of the prosthesis with respect to the host bone measured by means of roentgen
stereophotogrammetric analysis (RSA).
- Patient Reported Outcome Measures by means of questionnaires.
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