Kinematics After Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Kinematics Following Total Knee Arthroplasty Performed With Different Surgical Alignment Techniques

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: DePuy ATTUNE total knee arthroplasty system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anatomic alignment<br>The aim of anatomic alignment is to recreate an individual's pre-operative alignment using the DePuy ATTUNE total knee arthroplasty system. | Device: DePuy ATTUNE total knee arthroplasty system<br>* A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.<br>|
| Active Comparator: Mechanical alignment<br>The aim of mechanical alignment is to achieve a neutral mechanical alignment regardless of pre-operative status, using the DePuy ATTUNE total knee arthroplasty system. | Device: DePuy ATTUNE total knee arthroplasty system<br>* A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |