RSA-RCT: Attune S+ TKA Versus Sigma TKA

NCT ID: NCT04037735

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2026-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ATTUNE

Total Knee Replacement with the ATTUNE S+ Knee Prosthesis by DePuy

Group Type: EXPERIMENTAL

ATTUNE S+ Knee Prosthesis by DePuy

Intervention Type: DEVICE

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

PFC Sigma

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

Group Type: ACTIVE_COMPARATOR

PFC Sigma Knee Prosthesis by DePuy

Intervention Type: DEVICE

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

Interventions

ATTUNE S+ Knee Prosthesis by DePuy

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

Intervention Type: DEVICE

PFC Sigma Knee Prosthesis by DePuy

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Peter den Hollander

OTHER

Sponsor Role: lead

Responsible Party

Peter den Hollander

Orthopedic Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter Hollander, MD

Role: PRINCIPAL_INVESTIGATOR

Haaglanden Medical Center

Rob G Nelissen, Prof.

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

Haaglanden Medical Center

The Hague, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Peter Hollander, MD

Role: CONTACT

P.den.Hollander@haaglandenmc.nl

+31 88 979 8087

Bart K Kaptein, PhD

Role: CONTACT

B.L.Kaptein@lumc.nl

+31715264542

Facility Contacts

Peter den Hollander, MD

Role: primary

p.den.hollander@haaglandenmc.nl

+31 88 979 8087

Other Identifiers

NL66908.098.18

Identifier Type: OTHER

Identifier Source: secondary_id

P18.131

Identifier Type: -

Identifier Source: org_study_id