Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain

Completed · Not applicable

Conditions studied: Osteoarthritis of the Knee

In brief

This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being completed at month 6. Subjects randomized to the comparison (HA) group will have the option to cross-over to the neurotomy group after completing the 6-month endpoint assessment. They will be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success. Subjects who were randomized to and received COOLIEF\* as their initial treatment will have the option to add 2 additional visits at 6-month intervals, representing 18 and 24 months post initial treatment.

Key facts

Study ID

NCT03381248

Run by

Avanos Medical

People needed

177

Starts

2017-12-07

Expected to finish

2020-07-20

Last updated by the study team

2023-10-10

Who can join

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

You may qualify if…

• Age ≥ 21 years
• Able to understand the informed consent form and provide written informed consent and 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 arthritis (x-ray/MRI/CT) of Osteoarthritis (OA) grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
• An intra-articular hyaluronic acid injection is indicated as an appropriate treatment option
• WOMAC Knee Score group at baseline of Score of ≥ 2 (0 to 4 scale) on WOMAC question 1 (Pain) and a mean score of ≥ 1.5 on all five questions of the WOMAC pain subscale.
• 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
• Willing to utilize double barrier contraceptive method if of child bearing potential.
• Willing to delay any surgical intervention for the index knee for the period of the study follow up
• Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study

You may not qualify if…

• Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) 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 on becoming pregnant during the study period
• Chronic pain associated with significant psychosocial dysfunction
• Beck's Depression Index score of > 22 (indicates clinically depressed state)
• Allergies to any of the medications to be used during the procedures, including known hypersensitivity (allergy) to hyaluronate preparations or allergies to avian or avian-derived products (including eggs, feathers, or poultry)
• 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 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 within 30 days prior to signing informed consent
• Subject unwilling or unable to comply with follow up schedule or protocol requirements

Where it is running

• Lyman Medical Research — Coeur d'Alene, Idaho, United States
• Ocshner Baptist Clinical Trials Unit — New Orleans, Louisiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Clinical Investigations, LLC — Edmond, Oklahoma, United States
• University Orthopedics Center — Altoona, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• Piedmont Comprehensive Pain Management — Anderson, South Carolina, United States
• University of Virginia — Charlottesville, Virginia, United States
• Virginia iSpine Physicians — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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