BALANCING AND FUNCTIONAL OUTCOMES IN PATIENTS WITH TOTAL KNEE ARTHROPLASTY

Brief description of study

The purpose of this research project is to determine whether balancing the tensions of the ligaments on each side of the knee (as your knee is flexed and extended) at the time of surgery affects your function and stability at different follow-up times. To accomplish the above purpose, several devices will be used. The first device that is used is called Verasense. This device measures and helps balance the tensions of the ligaments during your surgery. It is FDA cleared to be used in total knee surgery, and is supplied by OrthoSensor, Inc. The second device is an accelerometer, about the shape and size of a button, which is held in place with a strap; five units will be used, two around each knee, one around the waist. These will be used before your surgery and at standard follow-up times of 3 months, 6 months and 1 year. This device is not FDA approved for this use, but does not involve any additional risk. The third device will be force plates to measure forces. These devices measure the motions and forces of the knee as you perform different functions. These will be used pre-operatively and at standard follow-up times of 3 months, 6 months and 1 year. This device is not FDA approved for this use, but does not involve any additional risk.


Clinical Study Identifier: s19-00389


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