Kinematic Analysis of a PS, FB Primary Total Knee Arthroplasty (ATTUNE Knee System) Using Dynamic RSA

Summary

Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per year. Statistics indicate that for patients over 60 year old approximately one out of 20 will require corrective reoperations within 10 years after surgery. However, for patients younger than 60 years, approximately one out of 10 will require revision total knee arthroplasty within 10 years of surgery. As the number of younger patients is increasing, there has been a shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and implant longevity being the important issues for quality of patient care. Furthermore, it has been reported that up to 25% of patients are not satisfied with the functional results of their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However these are often static, because of even most advanced x-ray film exchanger limit the number of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction.

The purpose of this study is to investigate the effect of a new implant design on the post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A prospective randomized study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.

Conditions

• Osteoarthritis

Interventions

DEVICE

Primary Total Knee Arthroplasty (ATTUNE Knee System)

The patient will undergo primary Total Knee ArthroplastY use ATTUNE Knee System. During surgery a navigation system will be used to record preoperative joint kinematics under different tests. During the test the 6 degrees of freedom (DOF) of the joint will be computed and shown to the surgeon; these are the femoral rotation and translation pattern against flexion ranges. Navigation system will be also used to monitor the implant positioning and possible surgical bias. Dynamic RSA will be used to analyze the in vivo kinematics of the prosthesis at 6 months follow-up. The above mentioned motion tests will be performed 3 times. The first 2 will be executed to gain comfort with the experimental set-up with no X-ray exposure. During the last data is collected.

Sponsors & Collaborators

• DePuy International

  collaborator INDUSTRY

• Istituto Ortopedico Rizzoli

  lead OTHER

Principal Investigators

• Maurilio Marcacci, MD · Rizzoli Orthopaedic Institute

• Laura Bragonzoni, SportScience · Alma Mater Studiorum - University of Bologna

• Danilo Danilo, MD · Rizzoli Orthopaedic Institute

• Bontempi Marco, Physicist · Rizzoli Orthopaedic Institute

• Maria Pia Neri, MD · Rizzoli Orthopaedic Institute

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2015-07-31

Completion

2016-09-30

Countries

• Italy

Study Locations