NCT04037735: APKnee2-S+

RSA-RCT: Attune S+ TKA Versus Sigma TKA

Recruiting now NA Last updated 30 October 2023

What this trial tests

NA trial testing ATTUNE S+ Knee Prosthesis by DePuy in Osteoarthritis Arthritis in 64 participants. Currently enrolling.

Timeline

1 November 2019

Primary endpoint
1 June 2026

1 June 2026

Quick facts

Lead sponsor	Peter den Hollander
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	64
Start date	1 November 2019
Primary completion	1 June 2026
Estimated completion	1 June 2026
Sites	1 location across Netherlands

Drugs / interventions tested

• ATTUNE S+ Knee Prosthesis by DePuy
• PFC Sigma Knee Prosthesis by DePuy

Conditions studied

• Osteoarthritis Arthritis — all drugs for Osteoarthritis Arthritis →
• Joint Disease — all drugs for Joint Disease →
• Musculoskeletal Disease — all drugs for Musculoskeletal Disease →
• Rheumatic Diseases — all drugs for Rheumatic Diseases →

Sponsor

Peter den Hollander

Who can join

Adults 21 to 90, any sex, with Osteoarthritis Arthritis or Joint Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized controlled trial comparing tibial migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma design.
   Kaptein BL, den Hollander P, Thomassen B, Fiocco M, et al · · 2020 · cited 22× · PMID 32862688 · DOI 10.1302/0301-620x.102b9.bjj-2020-0096.r1