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

• ClinicalTrials.gov Identifier: NCT02204748
• Recruitment Status: Completed
• First Posted: July 30, 2014
• Results First Posted: February 4, 2016
• Last Update Posted: October 10, 2019
• Sponsor: The University of Tennessee, Knoxville
• Collaborator: DePuy Orthopaedics
• Information provided by (Responsible Party): Richard Komistek, The University of Tennessee, Knoxville

Study Description

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.

Condition or disease	Intervention/treatment
Total Knee Arthroplasty; Osteoarthritis	Device: DePuy Attune posterior stabilizing fixed bearing knee system

Study Design

• Study Type: Observational
• Actual Enrollment: 5 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty
• Study Start Date: November 2014
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend [ Time Frame: 3 months post-operative ]
   Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
2. Femoro-tibial Kinematics: Translation and Lift-off for Gait [ Time Frame: 3 months post-operative ]
   Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.
3. Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down [ Time Frame: 3 months post-operative ]
   Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
4. Femoro-tibial Kinematics - Deep Knee Bend [ Time Frame: 3 months post-operative ]
   Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
5. Femoro-tibial Kinematics - Gait [ Time Frame: 3 months post-operative ]
   Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.
6. Femoro-tibial Kinematics - Ramp Down [ Time Frame: 3 months post-operative ]
   Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.

Secondary Outcome Measures :

1. Max Ground Reaction Force - Deep Knee Bend [ Time Frame: 3 months post-operative ]
   Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
2. Max Ground Reaction Force - Gait [ Time Frame: 3 months post-operative ]
   Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
3. Max Ground Reaction Force - Ramp Down [ Time Frame: 3 months post-operative ]
   Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Exclusion Criteria:

- Pregnant or potentially pregnant females will be excluded from the study

Contacts and Locations

Locations

United States, North Carolina

OrthoCarolina Research Institute

Charlotte, North Carolina, United States, 28207

United States, Tennessee

The University of Tennessee

Knoxville, Tennessee, United States, 37996

Sponsors and Collaborators

The University of Tennessee, Knoxville

DePuy Orthopaedics

Investigators

• Principal Investigator: Adrija Sharma, Ph. D.; University of Tennessee
• Principal Investigator: William R Hamel, Ph. D.; University of Tennessee

More Information

• Responsible Party: Richard Komistek, Principal Investigator, The University of Tennessee, Knoxville
• ClinicalTrials.gov Identifier: NCT02204748
• Other Study ID Numbers: 13002; R011373503 ( Other Identifier: University of Tennessee )
• First Posted: July 30, 2014
• Results First Posted: February 4, 2016
• Last Update Posted: October 10, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases