Kinematics After Total Knee Arthroplasty

Kristin Zhao, PhD

Status: Withdrawn

Conditions: Osteoarthritis, Knee

Treatments: Device: DePuy ATTUNE total knee arthroplasty system

Study type: Interventional

Funder types: Other

Identifiers

NCT03093077

15-008300

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Anatomic alignment

Experimental group

Description:

The aim of anatomic alignment is to recreate an individual's pre-operative alignment using the DePuy ATTUNE total knee arthroplasty system.

Treatment:

Device: DePuy ATTUNE total knee arthroplasty system

Mechanical alignment

Active Comparator group

Description:

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.

Treatment:

Device: DePuy ATTUNE total knee arthroplasty system