Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-11-30
2018-04-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Anatomic alignment
The aim of anatomic alignment is to recreate an individual's pre-operative alignment using the DePuy ATTUNE total knee arthroplasty system.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Primary arthroplasty for treatment of osteoarthritis
* Age between 40 and 80 years old
* Willingness to provide written consent for study participation
Exclusion Criteria
* 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
40 Years
80 Years
ALL
No
Sponsors
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Kristin Zhao, PhD
OTHER
Responsible Party
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Kristin Zhao, PhD
Principal Investigator
Principal Investigators
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Kristin D. Zhao, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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15-008300
Identifier Type: -
Identifier Source: org_study_id
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