Kinematics After Total Knee Arthroplasty

Kinematics Following Total Knee Arthroplasty Performed With Different Surgical Alignment Techniques

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: DePuy ATTUNE total knee arthroplasty system

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anatomic alignment; 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; A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.
Active Comparator: Mechanical alignment; 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; A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Kristin Zhao, PhD

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 15-008300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED