RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA
Condition: Osteoarthritis Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases
MeSH terms: Osteoarthritis; Rheumatic Diseases; Joint Diseases; Musculoskeletal Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): ATTUNE™ Knee Prosthesis by DePuy; PFC Sigma Knee Prosthesis by DePuy
Intervention type(s): Device; Device
Intervention description(s): Total Knee Replacement (TKR) Surgery with ATTUNE™ Knee Prosthesis by DePuy; Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Comparative Study; Knee Prosthesis; Prosthesis Design; Treatment Outcome; Follow-Up Studies; Arthroplasty, Replacement, Knee/methods