Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2

NCT ID: NCT02613338

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-01-31

Brief Summary

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Specifically, posterior stabilizing (PS) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. To understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. This continuation of the study will analyze 30 subjects with the Attune PS FB 3 months post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend.

Conditions

Total Knee Arthroplasty; Osteoarthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

DePuy Attune PS FB knee system

Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system

DePuy Attune posterior stabilizing fixed bearing knee system

Intervention Type: DEVICE

Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.

Interventions

DePuy Attune posterior stabilizing fixed bearing knee system

Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At least three (3) months post-operative with no other surgical procedures conducted within the past six months

• Between 30-80 years of age
• Body weight of less than 280 lbs
• Must be between 160cm (5'3) and 193cm (6'4) tall
• Body Mass Index (BMI) >18.5 and <35
• Judged clinically successful with a Knee Society score (KSS) of greater than 80
• Have good-to-excellent post-operative passive flexion with no ligamentous laxity or pain
• Must be able to walk on level ground without aid of any kind, perform a ramp descent, and a deep knee bend (DKB), all without assistance
• Will have a DePuy Attune PS TKA

Exclusion Criteria

• Pregnant or potentially pregnant females will be excluded from the study.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Synthes

INDUSTRY

Sponsor Role: collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role: lead

Responsible Party

Richard Komistek

Fred M. Roddy Professor of Biomedical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrija Sharma, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

William R Hamel, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Abercrombie Radiology

Knoxville, Tennessee, United States

Dougherty Engineering Building, Room M007

Knoxville, Tennessee, United States

Perkins Hall, The University of Tennessee

Knoxville, Tennessee, United States

Science and Engineering Research Facility, The University of Tennessee

Knoxville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IIS-13002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

9568FB

Identifier Type: -

Identifier Source: org_study_id