RSA-RCT: Attune S+ TKA Versus 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) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up).

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, more than 470,000 patients have received an Attune Knee 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 knee 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.

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 knee replacement surgery at the Department of Orthopaedics, Haags Medisch Centrum The Hague (HMC), The Netherlands. Annually 350 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, measured by means of RSA.
* Patient Reported Outcome Measures by means of questionnaires.

Conditions

• Osteoarthritis Arthritis
• Joint Disease
• Musculoskeletal Disease
• Rheumatic Diseases

Interventions

DEVICE

ATTUNE S+ Knee Prosthesis by DePuy

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

DEVICE

PFC Sigma Knee Prosthesis by DePuy

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

Sponsors & Collaborators

• Leiden University Medical Center

  collaborator OTHER

• Peter den Hollander

  lead OTHER

Principal Investigators

• Peter Hollander, MD · Haaglanden Medical Center

• Rob G Nelissen, Prof. · Leiden University Medical Center

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

2019-11-01

Primary Completion

2026-06-01

Completion

2026-06-01

FDA Device

Yes

Countries

• Netherlands

Study Locations