Preop Cooled Radiofrequency Ablation for Total Knee Replacement
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|ClinicalTrials.gov Identifier: NCT03893292|
Recruitment Status : Withdrawn (Lack of participants)
First Posted : March 28, 2019
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment|
|Postoperative Pain Knee Osteoarthritis||Procedure: Total knee replacement Device: COOLIEF|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Pilot Study on the Utility of Cooled Radiofrequency Ablation in Patients Prior to Total Knee Arthroplasty|
|Actual Study Start Date :||January 24, 2019|
|Actual Primary Completion Date :||October 30, 2020|
|Actual Study Completion Date :||October 30, 2020|
Preoperative cooled radiofrequency ablation
Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement.
Procedure: Total knee replacement
Patients will undergo total knee replacement surgery.
The superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated.
- Pain [ Time Frame: Up to 1 year post-total knee replacement ]Pain will be assessing on a 0-10 scale, where 0=no pain and 10=most pain.
- Knee Disability [ Time Frame: Up to 1 year post-total knee replacement ]Knee disability will be assessed using the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR). The score ranges from 0-100, where 0=total knee disability and 10=perfect health.
- Function assessed using the PROMIS-physical function computer adaptive test [ Time Frame: Up to 1 year post-total knee replacement ]Function will be assessed using the PROMIS-physical function computer adaptive test. A higher score indicates higher function.
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): NCT03893292
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Jonathan Kirschner, MD||Hospital for Special Surgery, New York|