RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA

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

Interventions

DEVICE

ATTUNE™ Knee Prosthesis by DePuy

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

DEVICE

PFC Sigma Knee Prosthesis by DePuy

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

Sponsors & Collaborators

• Medical Center Haaglanden

  collaborator OTHER

• DePuy International

  collaborator INDUSTRY

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• Rob G Nelissen, Prof. PhD, MD · Dep. Orthopaedics, Leiden University Medical Center

• Edward R Valstar, Prof. PhD. MSc · Dep. Orthopaedics, Leiden University Medical Center

• Peter H den Hollander, MD · Dep. Orthopaedics, Medisch Centrum Haaglanden

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2017-11-02

Completion

2017-11-02

Countries

• Netherlands

Study Locations