An observational study in Postoperative Pain and Knee Osteoarthritis, sponsored by Hospital for Special Surgery, New York. Withdrawn at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.
Sponsored by Hospital for Special Surgery, New York · Observational
Total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. However, 20% of patients continue to experience pain after surgery. There is currently no standardized pain management protocol for pain after total knee replacement. Cooled radiofrequency ablation has been used successfully to alleviate spin-related pain and has recently been approved by the FDA to treat chronic knee arthritic pain. This pilot study aims to collect preliminary data on the use of cooled radiofrequency ablation in patients undergoing total knee replacement.
The number of patients who undergo total knee replacement is rising significantly. However, many of these patients are dissatisfied with the results, because they continue to experience pain postoperatively. This pain can be debilitating and can also be associated with decreased quality of life. Given the increasing number of patients undergoing total knee replacement and a dissatisfaction rate of 8-44%, improvements must be made in pain management protocols to help decrease pain in the immediate postoperative period following total knee replacement. Cooled radiofrequency ablation is a procedure that uses water-cooled technology to denervate the sensory nerves. It is widely used in the spine and is increasingly being used in the knee to treat osteoarthritis. Existing studies have shown that it can significantly reduce pain in patients with chronic osteoarthritis. In terms of its potential benefit as a preoperative measure to minimize postoperative pain, the literature is sparse. Results from this study will be used to generate hypotheses and power for future studies.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
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Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
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Patients undergoing unilateral primary total knee replacement for the treatment of knee osteoarthritis
Exclusion Criteria:
Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement.
Procedure: Total knee replacement · Device: COOLIEF
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
Pain will be assessing on a 0-10 scale, where 0=no pain and 10=most pain.
Time frame: Up to 1 year post-total knee replacement
Knee Disability
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.
Time frame: Up to 1 year post-total knee replacement
Function assessed using the PROMIS-physical function computer adaptive test
Function will be assessed using the PROMIS-physical function computer adaptive test. A higher score indicates higher function.
Time frame: Up to 1 year post-total knee replacement
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Hospital for Special Surgery, New York