Preop Cooled Radiofrequency Ablation for Total Knee Replacement

Hospital for Special Surgery (HSS)

Status: Withdrawn

Conditions: Postoperative Pain; Knee Osteoarthritis

Treatments: Procedure: Total knee replacement; Device: COOLIEF

Study type: Observational

Funder types: Other

Identifiers

NCT03893292

2018-1149

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing unilateral primary total knee replacement for osteoarthritis
• Pain >6 (on a scale of 0-10)
• Body mass index: 21-35 kg/m2

Exclusion criteria

• Age <65 years
• Patients who are wheelchair bound
• History of inflammatory arthritis or rheumatic disease
• Body mass index <21 or >35 kg/m2
• Chronic opioid use
• Pregnant women
• Non-English speaking

Trial design

0 participants in 1 patient group

Preoperative cooled radiofrequency ablation

Description:

Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement.

Treatment:

Device: COOLIEF

Procedure: Total knee replacement