Osteoarthritis, Knee
Conditions
Brief summary
The purpose of this study is to evaluate and compare implant kinematics of conventional mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year post-operatively.
Detailed description
Participants will be randomized to receive a primary TKA using either an anatomic alignment or a conventional mechanical alignment technique. Participants will undergo a kinematic analysis of a deep knee bend using single-plane fluoroscopy at 1 year post-operatively. The primary outcome will be based on the 6 degree of freedom kinematics and associated joint component proximity during the knee bend task. Secondary outcomes include the Knee Society Score, the Knee Injury and Osteoarthritis Outcome Score, and the Forgotten Knee Score.
Interventions
DEVICEDePuy ATTUNE total knee arthroplasty system
A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.
Sponsors
Kristin Zhao, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males and females * Primary arthroplasty for treatment of osteoarthritis * Age between 40 and 80 years old * Willingness to provide written consent for study participation
Exclusion criteria
* Revision arthroplasty * Pre-operative knee flexion lower than 90 degrees * Varus knee deformity greater than 15 degrees * Pre-operative valgus knee deformity * Presence of infections, highly communicable diseases or metastatic disease * Significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing * Congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon's judgment, interfere with total knee prosthesis survival or success * Presence of previous prosthetic knee or hip replacement device * BMI \> 40 * Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task. | 1 year post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Participants perception of knee function, as determined by the Knee injury Osteoarthritis Outcome Score (KOOS) | 1 year post surgery |
| Participant's awareness of the joint implant, as determined by the Forgotten Joint Score (FJS-12) | 1 year post surgery |
| Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS) | 1 year post surgery |
Countries
United States
Outcome results
None listed