Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT02256098
Study type Interventional
Source Leiden University Medical Center
Status Completed
Phase N/A
Start date September 2014
Completion date November 2, 2017

See also
  Status Clinical Trial Phase
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Enrolling by invitation NCT02269254 - Persona Versus NexGen N/A
Completed NCT02257489 - Phase 1 Study of ACE-083 in Healthy Subjects Phase 1
Completed NCT01979731 - Effects Job Rotation in the Prevention of Work Related Musculoskeletal Disorders N/A
Active, not recruiting NCT01440153 - Additional Exercise Program in Professional Dancers N/A
Completed NCT00968266 - Improving Beliefs About Medication in Patients With Rheumatoid Arthritis N/A
Active, not recruiting NCT02172053 - Resistance Exercise to Improve Fatigue in Workplace (REW) N/A
Completed NCT00311103 - Disability of Musculoskeletal Origin in Community-dwelling Elderly N/A
Completed NCT01015716 - Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Intervention to Reduce Weight and Increase Workability in Health Care Workers Phase 1
Suspended NCT00606788 - Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning N/A
Completed NCT00131326 - A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip Phase 3
Recruiting NCT02595307 - Improving Informed Consent for Cleft Palate Repair N/A
Completed NCT02127281 - Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty. N/A
Completed NCT00131352 - A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee Phase 3
Completed NCT02090959 - An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy Phase 3
Enrolling by invitation NCT02717559 - Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up N/A
Completed NCT02390336 - Mobilization With Movement in Patients With Osteoarthritis of the Hip N/A
Active, not recruiting NCT01698762 - IADAPT-Third Phase
Completed NCT01826487 - Phase 3 Study of Ataluren in Patients With Nonsense Mutation Duchenne Muscular Dystrophy Phase 3
Recruiting NCT01544439 - Occlusal Splint and Counseling to Temporomandibular Disorder Phase 3