RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA

NCT ID: NCT02256098

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-11-02

Brief 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.

Conditions

Osteoarthritis Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ATTUNE™

Total Knee Replacement Surgery with ATTUNE™ Knee Prosthesis by DePuy

Group Type: EXPERIMENTAL

ATTUNE™ Knee Prosthesis by DePuy

Intervention Type: DEVICE

Total Knee Replacement (TKR) Surgery with ATTUNE™ Knee Prosthesis by DePuy

PFC Sigma

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

Group Type: ACTIVE_COMPARATOR

PFC Sigma Knee Prosthesis by DePuy

Intervention Type: DEVICE

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

Interventions

ATTUNE™ Knee Prosthesis by DePuy

Total Knee Replacement (TKR) Surgery with ATTUNE™ Knee Prosthesis by DePuy

Intervention Type: DEVICE

PFC Sigma Knee Prosthesis by DePuy

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty
• All consecutive patients ("usual care") are included to prevent selection bias in the migration analysis.
• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Haaglanden

OTHER

Sponsor Role: collaborator

DePuy International

INDUSTRY

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

R.G.H.H. Nelissen

Prof. PhD MD Head of the Department of Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rob G Nelissen, Prof. PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. Orthopaedics, Leiden University Medical Center

Edward R Valstar, Prof. PhD. MSc

Role: PRINCIPAL_INVESTIGATOR

Dep. Orthopaedics, Leiden University Medical Center

Peter H den Hollander, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. Orthopaedics, Medisch Centrum Haaglanden

Locations

Leiden University Medical Center

Leiden, , Netherlands

Medisch Centrum Haaglanden

The Hague, , Netherlands

Countries

Netherlands

Other Identifiers

P14.142

Identifier Type: -

Identifier Source: org_study_id