RSA RCT: Attune RP TKA Versus LCS RP TKA

Summary

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.

Conditions

• Osteoarthritis Arthritis
• Joint Disease
• Musculoskeletal Disease

Interventions

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

Sponsors & Collaborators

• Leiden University Medical Center

  collaborator OTHER

• Spaarne Gasthuis

  lead OTHER

Principal Investigators

• Rob G Nelissen, Prof PhD MD · Dep. Orthopaedics, Leiden University Medical Center

• Peter A Nolte, PhD MD · Dep. Orthopaedics, Spaarne Gasthuis

• Edward R Valstar, Prof PhD Msc · Dep. Orthopaedics, Leiden University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-25

Primary Completion

2021-06-05

Completion

2021-06-05

FDA Device

Yes

Countries

• Netherlands

Study Locations