Clinical trial NCT02613338: Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2
Official title: Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Osteoarthritis
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2015-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion
timeFrame: 3 months post-operative
measure: Femoro-tibial Kinematics - Medial Anterior/Posterior Motion
timeFrame: 3 months post-operative
measure: Femoro-tibial Kinematics - Axial Rotation
timeFrame: 3 months post-operative
measure: Femoro-tibial Kinematics - Weight-bearing Flexion
timeFrame: 3 months post-operative
Secondary outcomes:
measure: Max Ground Reaction Force - Deep Knee Bend
timeFrame: 3 months post-operative
measure: Max Ground Reaction Force - Gait
timeFrame: 3 months post-operative
measure: Max Ground Reaction Force - Ramp Down
timeFrame: 3 months post-operative
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Knoxville
country: United States
facility: Abercrombie Radiology
state: Tennessee
city: Knoxville
country: United States
facility: Dougherty Engineering Building, Room M007
state: Tennessee
city: Knoxville
country: United States
facility: Perkins Hall, The University of Tennessee
state: Tennessee
city: Knoxville
country: United States
facility: Science and Engineering Research Facility, The University of Tennessee
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Adrija Sharma, Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: William R Hamel, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: