Preop Cooled Radiofrequency Ablation for Total Knee Replacement

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03893292
• Other study ID #: 2018-1149
• Status: Withdrawn
• Start date: January 24, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain will be assessing on a 0-10 scale, where 0=no pain and 10=most pain.	Up to 1 year post-total knee replacement
Secondary	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.	Up to 1 year post-total knee replacement
Secondary	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.	Up to 1 year post-total knee replacement