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

NCT02613338 | Completed Results

• 2 other identifiers: 9568FBIIS-13002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (4)

• Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion

  Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down

  3 months post-operative

• Femoro-tibial Kinematics - Medial Anterior/Posterior Motion

  Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down

  3 months post-operative

• Femoro-tibial Kinematics - Axial Rotation

  Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia.

  3 months post-operative

• Femoro-tibial Kinematics - Weight-bearing Flexion

  Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.

  3 months post-operative

Secondary Outcomes (3)

• Max Ground Reaction Force - Deep Knee Bend

  3 months post-operative

• Max Ground Reaction Force - Gait

  3 months post-operative

• Max Ground Reaction Force - Ramp Down

  3 months post-operative

Study Arms (1)

DePuy Attune PS FB knee system

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

Device: DePuy Attune posterior stabilizing fixed bearing knee system

Interventions

DePuy Attune posterior stabilizing fixed bearing knee system DEVICE

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

DePuy Attune PS FB knee system

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• DePuy Synthes: collaborator

Study Sites (5)

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Abercrombie Radiology

Knoxville, Tennessee, 37909, United States

Location

Dougherty Engineering Building, Room M007

Knoxville, Tennessee, 37996, United States

Location

Perkins Hall, The University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Science and Engineering Research Facility, The University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Adrija Sharma, Principal Investigator
• Organization: University of Tennessee

adrija.sharma@utk.edu

8659747684

Study Officials

• Adrija Sharma, Ph. D.

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• William R Hamel, Ph. D.

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fred M. Roddy Professor of Biomedical Engineering

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)