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

NCT02204748 | Completed Results

• 2 other identifiers: 13002R011373503
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 2

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 pilot study will analyze 5 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. Since this is a pilot study, there is no hypothesis.

Conditions

Total Knee Arthroplasty; Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend

  Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.

  3 months post-operative

• Femoro-tibial Kinematics: Translation and Lift-off for Gait

  Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.

  3 months post-operative

• Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down

  Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.

  3 months post-operative

• Femoro-tibial Kinematics - Deep Knee Bend

  Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.

  3 months post-operative

• Femoro-tibial Kinematics - Gait

  Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.

  3 months post-operative

• Femoro-tibial Kinematics - Ramp Down

  Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.

  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 TKA

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

Device: DePuy Attune posterior stabilizing fixed bearing knee system

Interventions

DePuy Attune posterior stabilizing fixed bearing knee system DEVICE

DePuy Attune PS FB TKA

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

Patients will have been implanted with the DePuy Attune PS FB knee system by Dr. Thomas Fehring of OrthoCarolina, PA in Charlotte, NC.

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
• Must be willing to sign the Informed Consent (IC) and HIPAA forms to participate in the study

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 Orthopaedics: collaborator

Study Sites (2)

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

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, Ph. D.
• Organization: The University of Tennessee

asharma1@utk.edu

8659742093

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 10, 2019
• Results First Posted: February 4, 2016

Record last verified: 2019-10

Locations

US (2)