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Unanswered questions regarding indications for device.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anatomic alignment | Experimental | The aim of anatomic alignment is to recreate an individual's pre-operative alignment using the DePuy ATTUNE total knee arthroplasty system. |
|
| Mechanical alignment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy ATTUNE total knee arthroplasty system | Device | A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task. | 1 year post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin D. Zhao, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS) | 1 year post surgery |
| D012216 |
| Rheumatic Diseases |