Kinematics After Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Kinematics Following Total Knee Arthroplasty Performed With Different Surgical Alignment Techniques

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03093077
• Other study ID #: 15-008300
• Status: Withdrawn
• Phase: N/A
• First received: September 26, 2016
• Last updated: April 23, 2018
• Start date: November 2016
• Est. completion date: April 10, 2018

Study information

• Verified date: April 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Kristin Zhao, PhD

Country where clinical trial is conducted

United States, 

Outcome

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