RSA-RCT: Attune S+ TKA Versus Sigma TKA (APKnee2-S+)

A Clinical Randomized Controlled RSA Trial Comparing the Cemented Attune (S+ Tibia Tray) Fixed Bearing Cruciate Retaining Knee System With the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatic Diseases; Musculoskeletal Disease; Joint Disease; Osteoarthritis Arthritis
• Intervention / Treatment: Device: ATTUNE S+ Knee Prosthesis by DePuy; Device: PFC Sigma Knee Prosthesis by DePuy

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Hollander, MD; Phone Number: +31 88 979 8087; Email: P.den.Hollander@haaglandenmc.nl
• Study Contact Backup: Name: Bart K Kaptein, PhD; Phone Number: +31715264542; Email: B.L.Kaptein@lumc.nl

Study Locations

• Netherlands
  • Zuid Holland
    • The Hague, Zuid Holland, Netherlands, 2501CK
      • Recruiting
      • Haaglanden Medical Center
      • Contact: Peter den Hollander, MD; Phone Number: +31 88 979 8087; Email: p.den.hollander@haaglandenmc.nl
      • Principal Investigator: Peter den Hollander, MD
      • Principal Investigator: Rob G Nelissen, Prof
      • Sub-Investigator: Bart L Kaptein, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is diagnosed with osteoarthritis and requires 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
  • The patient is diagnosed with Rheumatoid Arthritis
  • 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 instruments because of bone defects or deformity of the bone
• When there are not enough markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATTUNE; Total Knee Replacement with the ATTUNE S+ Knee Prosthesis by DePuy	Device: ATTUNE S+ Knee Prosthesis by DePuy; Total Knee Replacement (TKR) Surgery with ATTUNE S+ Knee Prosthesis by DePuy
Active Comparator: PFC Sigma; Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy	Device: PFC Sigma Knee Prosthesis by DePuy; Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migration, Maximum Total Point Motion (MTPM in mm) measured by means of Radiostereometry (RSA)	Compare the magnitude and pattern of migration of the prostheses (Tibial and Femoral component, smaller MTPM is better) Migration is defined as the relative movement of the prosthesis with respect to the markers in the bone. MTPM is defined as Maximum Total Point Motion, which means the amount of motion of the point that moves the most.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D with 3 levels of severity for each of the 5 dimensions (EQ-5D-3L)	General Health: EuroQol 3 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire; Index, 0 (worst possible) - 100 (best possible).	2 Years
Knee injury and Osteoarthritis Outcome Score (KOOS-PS)	Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire; Index, 0 (worst possible) - 100 (best possible).	2 Years
Visual Analogue Scale (VAS) pain	Pain score after activity and during rest; Likert scale 0 (no-pain) -10 (extreme pain).	2 Years

Collaborators and Investigators

• Sponsor: Peter den Hollander
• Collaborators: Leiden University Medical Center
• Investigators: Principal Investigator: Peter Hollander, MD, Haaglanden Medical Center; Principal Investigator: Rob G Nelissen, Prof., Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Comparative Study; Treatment Outcome; Follow-Up Studies; Prosthesis Design; Knee Prosthesis
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Arthritis; Osteoarthritis; Joint Diseases; Rheumatic Diseases; Collagen Diseases; Musculoskeletal Diseases
• Other Study ID Numbers: P18.131; NL66908.098.18 (Other Identifier: https://www.toetsingonline.nl/)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes