RSA RCT: Attune RP TKA Versus LCS RP TKA (ALKNEE)

A CLINICAL RANDOMIZED CONTROLLED RSA TRIAL COMPARING THE CEMENTLESS ATTUNE ROTATING PLATFORM KNEE SYSTEM TO THE CEMENTLESS LCS ROTATING PLATFORM KNEE SYSTEM

The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement with a good clinical track record and good survival rates.

The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has been designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. It is expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval early 2016. Patient inclusion will start after regular approval has been obtained.

The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32 patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included.

The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95% is Osteo Arthritis (OA). The investigator anticipates 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: Completed
• Conditions: Musculoskeletal Disease; Joint Disease; Osteoarthritis Arthritis
• Intervention / Treatment: Device: ATTUNE Knee Prosthesis by DePuy; Device: LCS Knee Prosthesis by DePuy

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Hoofddorp, Netherlands, 2130AT
    • Spaarne Gasthuis
  • Leiden, Netherlands, 2300RC
    • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is diagnosed with osteoarthritis 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.

• Status after patellectomy
• In case flexion is less than 90 degrees
• 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
• Patient is diagnosed with rheumatoid arthritis
• 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 Surgery with cementless ATTUNE Rotating Platform Knee Prosthesis by DePuy	Device: ATTUNE Knee Prosthesis by DePuy; Total Knee Replacement (TKR) Surgery with cementless ATTUNE rotating platform Knee Prosthesis by DePuy; Device: LCS Knee Prosthesis by DePuy; Total Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy
Active Comparator: LCS; Total Knee Replacement Surgery with cementless LCS Rotating Platform Knee Prosthesis by DePuy	Device: ATTUNE Knee Prosthesis by DePuy; Total Knee Replacement (TKR) Surgery with cementless ATTUNE rotating platform Knee Prosthesis by DePuy; Device: LCS Knee Prosthesis by DePuy; Total Knee Replacement Surgery with cementless LCS rotating platform 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
VAS pain	Pain score after activity and during rest; (Likert scale 0-10)	2 Years
2 Anchor questions	Two anchor questions (Likert scale 1-7) about change in functioning and pain since surgery.	2 Years

Collaborators and Investigators

• Sponsor: Spaarne Gasthuis
• Collaborators: Leiden University Medical Center
• Investigators: Principal Investigator: Rob G Nelissen, Prof PhD MD, Dep. Orthopaedics, Leiden University Medical Center; Principal Investigator: Peter A Nolte, PhD MD, Dep. Orthopaedics, Spaarne Gasthuis; Principal Investigator: Edward R Valstar, Prof PhD Msc, Dep. Orthopaedics, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): June 5, 2021
• Study Completion (Actual): June 5, 2021

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Comparative study; Treatment Outcome; Prosthesis Design; Follow-up studies; Knee Prosthesis; Arthroplast, Replacement, Knee/methods
• Additional Relevant MeSH Terms: Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases; Musculoskeletal Diseases
• Other Study ID Numbers: 2017.0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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