Clinical trial NCT02204748: Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System
Official title: Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Osteoarthritis
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2014-07-30
Enrollment: 5
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: Patients will have been implanted with the DePuy Attune PS FB knee system by Dr. Thomas Fehring of OrthoCarolina, PA in Charlotte, NC.

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.


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
* 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

Primary outcomes:
measure: Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend
timeFrame: 3 months post-operative
measure: Femoro-tibial Kinematics: Translation and Lift-off for Gait
timeFrame: 3 months post-operative
measure: Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down
timeFrame: 3 months post-operative
measure: Femoro-tibial Kinematics - Deep Knee Bend
timeFrame: 3 months post-operative
measure: Femoro-tibial Kinematics - Gait
timeFrame: 3 months post-operative
measure: Femoro-tibial Kinematics - Ramp Down
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: 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: