Preop Cooled Radiofrequency Ablation for Total Knee Replacement

Withdrawn

• Conditions: Postoperative Pain; Knee Osteoarthritis
• Interventions: Procedure: Total knee replacement; Device: COOLIEF

• Registration Number: NCT03893292
• Lead Sponsor: Hospital for Special Surgery, New York

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.

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 Timeline

• Study Start: 2019-01-24
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-28
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preoperative cooled radiofrequency ablation	Total knee replacement	Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement.
Preoperative cooled radiofrequency ablation	COOLIEF	Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States