Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:8/30/2018
Start Date:October 11, 2017
End Date:April 2020
Contact:Mukesh Ahuja, MBBS, MS
Email:Mahuja@medacta.us.com
Phone:312-548-3368

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A Multi-center, Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique.

To compare economic factors and the rate of adverse events between two types of
instrumentation used for total knee replacement: Single-use Efficiency Instruments with
Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical
Technique


Inclusion Criteria:

- Age 18 to 75 years

- BMI ≤35

- Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or
post-traumatic OA)

- Able and willing to give consent and to comply with study requirements, including
follow up visit at 6 weeks

Exclusion Criteria:

- Pregnant women or those seeking to become pregnant. Pregnancy test is administered
prior to surgery as part of routine care by the hospital / surgery center for all
female patients of childbearing potential

- Is participating in another clinical study

- Has inflammatory arthritis

- Has knee avascular necrosis

- Has severe deformity, defined as greater than 10 degrees varus or valgus relative to
the mechanical axis

- Has retained hardware in the knee that requires removal or interferes with Total Knee
Arthroplasty (TKA) procedure
We found this trial at
4
sites
Austin, Texas 78759
Principal Investigator: Tyler Goldberg, MD
Phone: 512-439-1001
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640 Alden Street
Meadville, Pennsylvania 16335
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Richmond, Virginia 23255
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Richmond, VA
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West Jordan, UT
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