Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03381248
Recruitment Status : Completed
First Posted : December 21, 2017
Results First Posted : May 22, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Avanos Medical

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 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Device: Cooled Radiofrequency Biological: Hyaluronic Acid Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Clinical Trial Evaluating the Safety and Effectiveness of Using COOLIEF™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing a Single Injection of Hyaluronic Acid in the Management of Knee Pain
Actual Study Start Date : December 7, 2017
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : July 20, 2020


Arm Intervention/treatment
Experimental: Cooled Radiofrequency
Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain
Device: Cooled Radiofrequency
Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Other Name: Coolief

Active Comparator: Hyaluronic Acid Injection
Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain
Biological: Hyaluronic Acid
Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain
Other Name: Viscosupplementation




Primary Outcome Measures :
  1. Numeric Rating Scale (NRS) [ Time Frame: 6 months ]
    The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain". There are no sub-scales.

  2. Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow-up [ Time Frame: 6 months ]
    Safety: The proportion of subjects experiencing adverse events through final follow-up.


Secondary Outcome Measures :
  1. Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow-up [ Time Frame: 12, 18, and 24 months ]
    Safety: The proportion of subjects experiencing adverse events through final follow-up.

  2. Numeric Rating Scale [ Time Frame: 12, 18, and 24 months ]
    The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain". There are no sub-scales.

  3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 6 months ]
    The change in WOMAC score from baseline. This outcome instrument is composed of three sub-scales, including "Pain" (5 questions), "Stiffness" (2 questions), and "Physical Function" (17 questions). The point range for each sub-scale question is from 0 to 4, with "0" indicating the best study subject condition and "4" indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for "Pain", Stiffness", and "Physical Function", respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition).

  4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 12, 18, and 24 months ]
    The change in WOMAC score from baseline. This outcome instrument is composed of three sub-scales, including "Pain" (5 questions), "Stiffness" (2 questions), and "Physical Function" (17 questions). The point range for each sub-scale question is from 0 to 4, with "0" indicating the best study subject condition and "4" indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for "Pain", Stiffness", and "Physical Function", respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition).


Other Outcome Measures:
  1. EQ-5D-5L [ Time Frame: 6 months ]
    The change in measured EQ-5D-5L scale from baseline. This outcome instrument is composed of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with "1" indicating the best study subject condition and "5" indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.

  2. Global Perceived Effect [ Time Frame: 6 months ]
    Number of participants with improvement measured by the Global Perceived Effect scale. The Global Perceived Effect is a 7-point scale: 1 point = "worst ever", 2 points = "much worse", 3 points = "worse", 4 points = "not improved but not worse", 5 points = "improved", 6 points = "much improved", 7 points = "best ever". There are no sub-scales. Number of participants scoring at either 5, 6, or 7 points on the Global Perceived Effect scale are reported.

  3. EQ-5D-5L [ Time Frame: 12, 18, and 24 months ]
    The change in measured EQ-5D-5L scale from baseline. This outcome instrument is composed of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with "1" indicating the best study subject condition and "5" indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.

  4. Global Perceived Effect [ Time Frame: 12, 18, and 24 months ]
    Number of participants with improvement measured by the Global Perceived Effect scale. The Global Perceived Effect is a 7-point scale: 1 point = "worst ever", 2 points = "much worse", 3 points = "worse", 4 points = "not improved but not worse", 5 points = "improved", 6 points = "much improved", 7 points = "best ever". There are no sub-scales. Number of participants scoring at either 5, 6, or 7 points on the Global Perceived Effect scale are reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Age ≥ 21 years
  2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
  3. Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
  4. 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])
  5. Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
  6. Pain on NRS ≥ 6 on an 11-point scale for the index knee
  7. 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
  8. An intra-articular hyaluronic acid injection is indicated as an appropriate treatment option
  9. 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.
  10. 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
  11. Agree to see one physician (study physician) for knee pain during the study period
  12. Willing to utilize double barrier contraceptive method if of child bearing potential.
  13. Willing to delay any surgical intervention for the index knee for the period of the study follow up
  14. Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study

EXCLUSION CRITERIA

  1. Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain
  2. Evidence of neuropathic pain affecting the index knee
  3. Previous or pending lower limb amputation
  4. Intra-articular steroid injection into the index knee within 90 days from randomization
  5. Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
  6. Prior radiofrequency ablation of the genicular nerves of the index knee
  7. Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
  8. Clinically significant ligamentous laxity of the index knee
  9. 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
  10. Body mass index (BMI) > 40 kg/m2
  11. 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
  12. Pending or active compensation claim, litigation or disability remuneration (secondary gain)
  13. Pregnant, nursing or intent on becoming pregnant during the study period
  14. Chronic pain associated with significant psychosocial dysfunction
  15. Beck's Depression Index score of > 22 (indicates clinically depressed state)
  16. 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)
  17. Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
  18. History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable.
  19. Identifiable anatomical variability that would materially alter the procedure as described in the protocol
  20. Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse
  21. Current prescribed opioid medications greater than 60 morphine equivalent daily opioid dose
  22. Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
  23. Subject currently implanted with pacemaker, stimulator or defibrillator.
  24. Participating in another clinical trial/investigation within 30 days prior to signing informed consent
  25. Subject unwilling or unable to comply with follow up schedule or protocol requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381248


Locations
Layout table for location information
United States, Idaho
Lyman Medical Research
Coeur d'Alene, Idaho, United States, 83814
United States, Louisiana
Ocshner Baptist Clinical Trials Unit
New Orleans, Louisiana, United States, 70115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Oklahoma
Clinical Investigations, LLC
Edmond, Oklahoma, United States, 73013
United States, Pennsylvania
University Orthopedics Center
Altoona, Pennsylvania, United States, 16602
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, South Carolina
Piedmont Comprehensive Pain Management
Anderson, South Carolina, United States, 29621
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Virginia iSpine Physicians
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
Avanos Medical
Investigators
Layout table for investigator information
Principal Investigator: Antonia F Chen, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Avanos Medical:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Avanos Medical
ClinicalTrials.gov Identifier: NCT03381248    
Other Study ID Numbers: 105-17-0001
First Posted: December 21, 2017    Key Record Dates
Results First Posted: May 22, 2020
Last Update Posted: November 13, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Avanos Medical:
randomized clinical trial
osteoarthritis
radiofrequency ablation
knee
genicular
cross-over
viscosupplementation
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents