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

Tuckahoe Orthopedics

Richmond, Virginia 23255

from

Richmond, VA