Status:
COMPLETED
Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain
Lead Sponsor:
Avanos Medical
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 gen...
Detailed Description
The COOLIEF™ system components utilized in the study are the same in form and function regardless of specific product branding (COOLIEF\* or SInergy\*). The COOLIEF™ system is comprised of three prima...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
- EXCLUSION CRITERIA
- 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
Exclusion
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2020
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT03381248
Start Date
December 7 2017
End Date
July 20 2020
Last Update
October 10 2023
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Lyman Medical Research
Coeur d'Alene, Idaho, United States, 83814
2
Ocshner Baptist Clinical Trials Unit
New Orleans, Louisiana, United States, 70115
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Clinical Investigations, LLC
Edmond, Oklahoma, United States, 73013