Preop Cooled Radiofrequency Ablation for Total Knee Replacement
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
Device: COOLIEF
The superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated.
|
Outcome Measures
Primary Outcome Measures
- Pain [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.
Secondary Outcome Measures
- Knee Disability [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergoing unilateral primary total knee replacement for osteoarthritis
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Pain >6 (on a scale of 0-10)
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Body mass index: 21-35 kg/m2
Exclusion Criteria:
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Age <65 years
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Patients who are wheelchair bound
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History of inflammatory arthritis or rheumatic disease
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Body mass index <21 or >35 kg/m2
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Chronic opioid use
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Pregnant women
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Non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital for Special Surgery | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Hospital for Special Surgery, New York
Investigators
- Principal Investigator: Jonathan Kirschner, MD, Hospital for Special Surgery, New York
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-1149