Back to resultsKinematics After Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DePuy ATTUNE total knee arthroplasty system
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis, Knee
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anatomic alignment
Mechanical alignment
Arm Description
The aim of anatomic alignment is to recreate an individual's pre-operative alignment using the 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.
Outcomes
Primary Outcome Measures
Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task.
Secondary Outcome Measures
Participants perception of knee function, as determined by the Knee injury Osteoarthritis Outcome Score (KOOS)
Participant's awareness of the joint implant, as determined by the Forgotten Joint Score (FJS-12)
Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03093077
Brief Title
Kinematics After Total Knee Arthroplasty
Official Title
Kinematics Following Total Knee Arthroplasty Performed With Different Surgical Alignment Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Unanswered questions regarding indications for device.
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 10, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristin Zhao, PhD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anatomic alignment
Arm Type
Experimental
Arm Description
The aim of anatomic alignment is to recreate an individual's pre-operative alignment using the DePuy ATTUNE total knee arthroplasty system.
Arm Title
Mechanical alignment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
DePuy ATTUNE total knee arthroplasty system
Intervention Description
A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Participants perception of knee function, as determined by the Knee injury Osteoarthritis Outcome Score (KOOS)
Time Frame
1 year post surgery
Title
Participant's awareness of the joint implant, as determined by the Forgotten Joint Score (FJS-12)
Time Frame
1 year post surgery
Title
Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS)
Time Frame
1 year post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin D. Zhao, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Kinematics After Total Knee Arthroplasty
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