An interventional study of DePuy ATTUNE total knee arthroplasty system in Osteoarthritis, Knee, sponsored by Kristin Zhao, PhD. Withdrawn at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-25.
Sponsored by Kristin Zhao, PhD · Not applicable, Interventional, and Basic science
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.
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
Browse Osteoarthritis, Knee studies →Kristin Zhao, PhD is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.
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
Participants perception of knee function, as determined by the Knee injury Osteoarthritis Outcome Score (KOOS)
Time frame: 1 year post surgery
Participant's awareness of the joint implant, as determined by the Forgotten Joint Score (FJS-12)
Time frame: 1 year post surgery
Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS)
Time frame: 1 year post surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Kristin Zhao, PhD