RSA-RCT: Attune S+ TKA Versus Sigma TKA

NCT04037735 | Recruiting FDA Device

• 2 other identifiers: P18.131NL66908.098.18
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

Comparative Study; Knee Prosthesis; Prosthesis Design; Treatment Outcome; Follow-Up Studies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• EQ-5D with 3 levels of severity for each of the 5 dimensions (EQ-5D-3L)

  2 Years

• Knee injury and Osteoarthritis Outcome Score (KOOS-PS)

  2 Years

• Visual Analogue Scale (VAS) pain

  2 Years

Study Arms (2)

ATTUNE

EXPERIMENTAL

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

Device: ATTUNE S+ Knee Prosthesis by DePuy

PFC Sigma

ACTIVE COMPARATOR

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

Device: PFC Sigma Knee Prosthesis by DePuy

Interventions

ATTUNE S+ Knee Prosthesis by DePuy DEVICE

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

ATTUNE

PFC Sigma Knee Prosthesis by DePuy DEVICE

Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy

PFC Sigma

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter den Hollander: lead
• Leiden University Medical Center: collaborator

Study Sites (1)

Haaglanden Medical Center

The Hague, South Holland, 2501CK, Netherlands

RECRUITING

MeSH Terms

Conditions

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Hollander, MD

  Haaglanden Medical Center

  PRINCIPAL INVESTIGATOR

• Rob G Nelissen, Prof.

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Hollander, MD

CONTACT

+31 88 979 8087; P.den.Hollander@haaglandenmc.nl

Bart K Kaptein, PhD

CONTACT

+31715264542; B.L.Kaptein@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: November 1, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

NL (1)