Evaluation of PRO After TKA Under Spinal Anesthesia



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:50 - Any
Updated:6/9/2018
Start Date:December 6, 2016
End Date:December 2019
Contact:Germaine Cuff
Email:germaine.cuff@nyumc.org
Phone:212-263-5072

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Evaluation of the Patient Reported Outcomes After Sensor-guided Total Knee Arthroplasty Under Spinal Anesthesia With Limited Motor-block.

The purpose of this study will be to evaluate and compare patients undergoing total knee
arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient
will be assessed for the difference between passive, soft tissue controlled, pressure balance
and muscle activated pressure balance.

This is a randomized prospective study looking at the impact sensor guidance has on the
outcome of patients and comparing to that of patients with a standard technique. The study is
also designed to evaluate the difference between passive, soft tissue controlled, pressure
balance and muscle activated pressure balance. Prior to the randomized study, there will be
an observational pilot of 25 patients. These patients will not be randomized and will receive
standard of care anesthesia. The reason for the 25 pilot patients is to perfect the sensor
guidance so all subsequent study patients will have a streamlined, consistent measurement.

Inclusion Criteria:

- Patients will be screened for eligibility based on whether they have chronic knee pain
as a result of an arthritis-related condition.

- Patient with chronic knee pain who is indicated for total hip or knee replacement
surgery

- Patient is at least 50 years of age

- Patient is willing to participate in pre- and postoperative surveys

Exclusion Criteria:

- Failure to complete pre-operative surveys.

- Revision Total Knee Arthroplasty

- Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy

- Contralateral Total Knee Arthroplasty

- Prior tibial plateau fracture

- Ligamentous Insufficiency

- History of fibromyalgia, chronic fatigue syndrome
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Arthur Atchabahian, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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