RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA (APKnee)

A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE™ 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)(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.

Study Overview

• Status: Completed
• Conditions: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteoarthritis Arthritis
• Intervention / Treatment: Device: PFC Sigma Knee Prosthesis by DePuy; Device: ATTUNE™ Knee Prosthesis by DePuy

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Den Haag, Netherlands, 2501CK
    • Medisch Centrum Haaglanden
  • Leiden, Netherlands, 2300RC
    • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• 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
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
Experimental: ATTUNE™; Total Knee Replacement Surgery with ATTUNE™ Knee Prosthesis by DePuy	Device: ATTUNE™ Knee Prosthesis by DePuy; Total Knee Replacement (TKR) Surgery with ATTUNE™ Knee Prosthesis by DePuy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migration, measured by means of RSA.	Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D	General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire	2 Years
KOOS	Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire	2 Years
2 Anchor questions	Two anchor questions (Likert scale 1-7) about change in functioning and pain since surgery.	2 Years
VAS pain	- Pain score after activity and during rest; (Likert scale 0-10)	2 Years

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Medical Center Haaglanden; DePuy International
• Investigators: Principal Investigator: Edward R Valstar, Prof. PhD. MSc, Dep. Orthopaedics, Leiden University Medical Center; Principal Investigator: Rob G Nelissen, Prof. PhD, MD, Dep. Orthopaedics, Leiden University Medical Center; Principal Investigator: Peter H den Hollander, MD, Dep. Orthopaedics, Medisch Centrum Haaglanden

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): November 2, 2017
• Study Completion (Actual): November 2, 2017

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (Estimate): October 3, 2014

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Comparative Study; Treatment Outcome; Follow-Up Studies; Prosthesis Design; Knee Prosthesis; Arthroplasty, Replacement, Knee/methods
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Arthritis; Osteoarthritis; Joint Diseases; Rheumatic Diseases; Collagen Diseases; Musculoskeletal Diseases
• Other Study ID Numbers: P14.142