Orthosensor vs Conventional Total Knee Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03628378|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: Verasense||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Outcomes in Free-hand Versus Sensor-guided Balancing in Total Knee Arthroplasty: a Randomized Controlled Trial|
|Actual Study Start Date :||December 20, 2017|
|Estimated Primary Completion Date :||December 20, 2020|
|Estimated Study Completion Date :||March 20, 2021|
No Intervention: Non-Sensor Group
Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.
Experimental: Sensor Group
Patients will undergo total knee replacement surgery with Verasense assisted balancing technology.
Ligamentous balancing device
Other Name: Orthosensor
- Veterans RAND12 Item Health Survey [ Time Frame: 1 year ]The investigators will ask participants to answer survey questions about knee functionality on a scale of 0-100, 0 being the least functionality and 100 being the most.
- Visual Analogue Scale pain level [ Time Frame: 1 week ]Pain levels on a scale from 1-10 (1 being the least amount of pain possible and 10 being the most amount of pain possible).
- Ambulation (distance) [ Time Frame: 1 week ]ambulation distance during inpatient physical therapy postoperatively
- Range of motion [ Time Frame: 1 year ]physical examination of knee
- KOOS Knee Survey [ Time Frame: 1 year ]The investigators will ask participants to answer survey questions about knee functionality on a scale of 0-100, 0 being the least functionality and 100 being the most.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628378
|United States, New York|
|NewYork-Presbyterian Lawrence Hospital|
|Bronxville, New York, United States, 10708|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Jeffrey Geller, MD||Columbia University|