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

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

sites

Texas Orthopedics

Austin, Texas 78759

Principal Investigator: Tyler Goldberg, MD

Phone: 512-439-1001

from

Austin, TX