NCT03893292

Preop Cooled Radiofrequency Ablation for Total Knee Replacement

A Pilot Study on the Utility of Cooled Radiofrequency Ablation in Patients Prior to Total Knee Arthroplasty

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Postoperative Pain
• Knee Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-24
• Primary completion: 2020-10-30
• Completion: 2020-10-30
• First posted: 2019-03-28
• Last updated: 2020-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study