Kinematics After Total Knee Arthroplasty

NCT03093077 | Withdrawn

• 1 other identifier: 15-008300
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Anatomic alignment

EXPERIMENTAL

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

Mechanical alignment

ACTIVE COMPARATOR

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

Interventions

DePuy ATTUNE total knee arthroplasty system DEVICE

A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.

Anatomic alignment; Mechanical alignment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• Primary arthroplasty for treatment of osteoarthritis
• Age between 40 and 80 years old
• Willingness to provide written consent for study participation

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristin Zhao, PhD: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kristin D. Zhao, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: March 28, 2017
• Study Start: November 1, 2016
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

US (1)