Kinematics After Total Knee Arthroplasty

Not Applicable

Withdrawn

• Conditions: Osteoarthritis, Knee
• Interventions: Device: DePuy ATTUNE total knee arthroplasty system

• Registration Number: NCT03093077
• Lead Sponsor: Kristin Zhao, PhD

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.

Study Timeline

• Study First Submitted: 2016-09-26
• Study Start: 2016-11
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Status Verified: 2018-04
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS)	1 year post surgery
Participant's awareness of the joint implant, as determined by the Forgotten Joint Score (FJS-12)	1 year post surgery
Participants perception of knee function, as determined by the Knee injury Osteoarthritis Outcome Score (KOOS)	1 year post surgery

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States