Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain

Completed · Not applicable

Conditions studied: Osteoarthritis of the Knee

In brief

This study is being performed to assess the relative effectiveness of genicular nerve ablation with the COOLIEF\* Cooled Radiofrequency probe to manage moderate to severe knee pain in patients with osteoarthritis (OA) of the knee when compared to radiofrequency ablation using a Standard Radiofrequency probe.

Key facts

Study ID

NCT04145011

Run by

Avanos Medical

People needed

153

Starts

2019-10-04

Expected to finish

2022-10-10

Last updated by the study team

2023-08-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 21 years
• Able to understand and personally sign and date the informed consent form
• Able to complete outcome measures
• Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
• Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs])
• Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
• Pain on NRS ≥ 6 on an 11-point scale for the index knee
• Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) grade 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
• Analgesics including membrane stabilizers such as Neurontin (gabapentin) and antidepressants for pain, such as Cymbalta (duloxetine), must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the course of the study without approval of the investigator
• Agree to see one physician (study physician) for knee pain during the study period
• Subjects of child bearing potential must be willing to utilize double barrier contraceptive method
• Willingness to comply with the requirements of this protocol for the full duration of the study (24 months regardless of effect of initial therapy)

You may not qualify if…

• Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic inflammatory condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause knee pain
• Evidence of neuropathic pain affecting the index knee
• Previous or pending lower limb amputation
• Intra-articular steroid injection into the index knee within 90 days from randomization
• Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
• Prior radiofrequency ablation of the genicular nerves of the index knee
• Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
• Clinically significant ligamentous laxity of the index knee
• Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations
• Body mass index (BMI) > 40 kg/m2
• Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the risk of skin burns
• Pending or active compensation claim, litigation, or disability remuneration (secondary gain)
• Pregnant, nursing or intent of becoming pregnant during the study period
• Chronic pain associated with significant psychosocial dysfunction
• Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator
• Allergies to any of the medications to be used during the procedures
• Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
• History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable
• Identifiable anatomical variability that would materially alter the procedure as described in the protocol
• Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse
• Current prescribed opioid medications greater than 60 mg morphine equivalent daily opioid dose
• Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
• Subject currently implanted with pacemaker, stimulator or defibrillator
• Participating in another clinical trial/investigation which included therapeutic treatment within 30 days prior to signing informed consent
• Subject unwilling or unable to comply with follow up schedule, protocol requirements or procedures

Where it is running

• University Orthopedics Center — Altoona, Pennsylvania, United States
• Pain Diagnostics and Interventional Care — Sewickley, Pennsylvania, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• Piedmont Comprehensive Pain Management — Anderson, South Carolina, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States
• The Spine and Nerve Centers of St. Francis Hosptial — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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