Clinical trial NCT03893292: Preop Cooled Radiofrequency Ablation for Total Knee Replacement
Official title: A Pilot Study on the Utility of Cooled Radiofrequency Ablation in Patients Prior to Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Postoperative Pain
Knee Osteoarthritis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing unilateral primary total knee replacement for the treatment of knee osteoarthritis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: Up to 1 year post-total knee replacement
Secondary outcomes:
measure: Knee Disability
timeFrame: Up to 1 year post-total knee replacement
measure: Function assessed using the PROMIS-physical function computer adaptive test
timeFrame: Up to 1 year post-total knee replacement
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jonathan Kirschner, MD
role: PRINCIPAL_INVESTIGATOR
References: