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Clinical Trials/NCT03093077
NCT03093077
Withdrawn
N/A

Kinematics Following Total Knee Arthroplasty Performed With Different Surgical Alignment Techniques

Kristin Zhao, PhD1 site in 1 countryNovember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Kristin Zhao, PhD
Locations
1
Primary Endpoint
Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task.
Status
Withdrawn
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
April 10, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kristin Zhao, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Kristin Zhao, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task.

Time Frame: 1 year post surgery

Secondary Outcomes

  • Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS)(1 year post surgery)
  • 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)

Study Sites (1)

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