Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain

• Sponsor: Avanos Medical (Other)
• Overall Status: Completed
• CT.gov ID: NCT03381248
• Collaborator: (none)
• Enrollment: 177
• Locations: 10
• Arms: 2
• Actual Duration (Months): 31.4
• Patients Per Site: 17.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

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 primary components (collectively known as 'disposables') and is used in conjunction with the Pain Management generator, pump unit, connector cables (collectively known as 'Hardware') and dispersive electrodes (also known as 'grounding pads'):

• Cooled Radiofrequency Sterile Tube Kit (sterile, single use, non-body contact): It is used for closed-loop circulation of sterile water through a Halyard Health* Cooled Radiofrequency Probe. It includes a burette and tubing.

• Cooled Radiofrequency Introducer (sterile, single use): It is to be used with the Probes only. The Cooled Radiofrequency Introducer provides a path for the Probe to the targeted nervous tissue.

• Cooled Radiofrequency Probe (sterile, single use): It is inserted through an Introducer into or near nervous tissue. The active tip extends 4mm from the introducer and delivers energy. Sterile water circulates internally to cool the Probe while it delivers radiofrequency energy. A thermocouple in the Probe measures the cooled electrode temperature throughout the procedure.

The product is comprised of an electrically insulated shaft with an active tip that functions as an electrode for radiofrequency energy delivery, a handle, tubes with luer locks and a cable with a 7-pin connector. The Introducer includes an insulated stainless steel cannula and a stylet. The Tube Kit is comprised of a burette and flexible tubing fitted with luer locks for connection to the Probe. The Probe, Introducer, and Tube Kit are ethylene oxide sterilized and supplied sterile. These components can be packaged together in a kit or as separate components. The devices should be stored in a cool, dry environment. The Instructions For Use (IFU) documents (Appendix 1) are included in each kit.

Halyard Health maintains a list of all model numbers and sizes for the system components.

The control product/device, Synvisc-One® (hylan G-F 20) (HA), is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium hyaluronate). Hylan G-F 20 is unique in that the hyaluronan is chemically crosslinked. Hyaluronan is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine.

Synvisc-One is a single injection regimen therapy indicated for the treatment of pain in Osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.

Following treatment, subjects in the CRF treatment group will follow up at 1, 3, 6 and 12 months. These subjects will then have the option to return for two additional visits at 18 and 24 months. Subjects initially randomized to the comparison (HA) group will follow up at 1, 3, and 6 months, and then be given the option to receive crossover CRF treatment. If crossover CRF treatment was received, subjects will return for follow up visits at 1, 3, and 6 months post-treatment. If crossover treatment was not received, subjects will return for their final 12 month visit.

Study Duration:

• Treatment Group: Up to 24 months following index procedure

• Control Group: Up to 13 months, depending upon receipt of cross-over procedure.

Effectiveness Endpoints:

• Numeric Rating Scale (NRS, Usual Level of Pain)

• Western Ontario & McMaster University Osteoarthritis Index (WOMAC)

• EQ-5D-5L Health-Related Quality of Life Questionnaire

• Global Perceived Effect Scale

Study Design

• Study Type: Interventional
• 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: Dec 7, 2017
• Actual Primary Completion Date: Feb 8, 2019
• Actual Study Completion Date: Jul 20, 2020

Arms and Interventions

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 Names: 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 Names: Viscosupplementation

Outcome Measures

Primary Outcome Measures

1. Numeric Rating Scale (NRS) [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 [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 [12, 18, and 24 months]

   Safety: The proportion of subjects experiencing adverse events through final follow-up.

2. Numeric Rating Scale [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) [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) [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	University Orthopedics Center	Altoona	Pennsylvania	United States	16602
6	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
7	University Orthopedics Center	State College	Pennsylvania	United States	16801
8	Piedmont Comprehensive Pain Management	Anderson	South Carolina	United States	29621
9	University of Virginia	Charlottesville	Virginia	United States	22908
10	Virginia iSpine Physicians	Richmond	Virginia	United States	23235

Sponsors and Collaborators

• Avanos Medical

Investigators

• Principal Investigator: Antonia F Chen, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 28, 2019

More Information

Publications

None provided.

• Responsible Party: Avanos Medical
• ClinicalTrials.gov Identifier: NCT03381248
• Other Study ID Numbers: 105-17-0001
• First Posted: Dec 21, 2017
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• 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: Osteoarthritis; Osteoarthritis, Knee; Hyaluronic Acid

Study Results

Participant Flow

Arm/Group Title	Cooled Radiofrequency	Hyaluronic Acid Injection
Arm/Group Description	Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain
Period Title: Overall Study
STARTED	89	88
COMPLETED	76	82
NOT COMPLETED	13	6

Baseline Characteristics

Arm/Group Title	Cooled Radiofrequency	Hyaluronic Acid Injection	Total
Arm/Group Description	Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain	Total of all reporting groups
Overall Participants	89	88	177
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.3 (10.7)	63.1 (9.7)	63.2 (10.2)
Sex: Female, Male (Count of Participants)
Female	52 58.4%	54 61.4%	106 59.9%
Male	37 41.6%	34 38.6%	71 40.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 2.2%	0 0%	2 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 3.4%	8 9.1%	11 6.2%
White	83 93.3%	80 90.9%	163 92.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 1.1%	0 0%	1 0.6%
Region of Enrollment (participants) [Number]
United States	89 100%	88 100%	177 100%

Outcome Measures

1. Primary Outcome

Title	Numeric Rating Scale (NRS)
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

76 of the 89 originally-randomized study subjects in the Cooled Radiofrequency group completed this 6-month outcome. 82 of the originally-randomized 88 study subjects in the Hyaluronic Acid Injection group completed this 6-month outcome.

Arm/Group Title	Cooled Radiofrequency	Hyaluronic Acid Injection
Arm/Group Description	Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain
Measure Participants	76	82
Count of Participants [Participants]	54 60.7%	31 35.2%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cooled Radiofrequency	Hyaluronic Acid Injection
Arm/Group Description	Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain
Measure Participants	89	88
Count of Participants [Participants]	48 53.9%	45 51.1%

3. Secondary Outcome

Title	Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow-up
Description	Safety: The proportion of subjects experiencing adverse events through final follow-up.
Time Frame	12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Numeric Rating Scale
Description	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.
Time Frame	12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description	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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cooled Radiofrequency	Hyaluronic Acid Injection
Arm/Group Description	Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain
Measure Participants	76	82
Mean (Standard Deviation) [units on a scale]	33.6 (22.9)	53.6 (22.9)

6. Secondary Outcome

Title	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description	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).
Time Frame	12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	EQ-5D-5L
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cooled Radiofrequency	Hyaluronic Acid Injection
Arm/Group Description	Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain
Measure Participants	76	82
Mean (Standard Deviation) [units on a scale]	0.80 (0.11)	0.72 (0.13)

8. Other Pre-specified Outcome

Title	Global Perceived Effect
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cooled Radiofrequency	Hyaluronic Acid Injection
Arm/Group Description	Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain
Measure Participants	76	82
Count of Participants [Participants]	55 61.8%	33 37.5%

9. Other Pre-specified Outcome

Title	EQ-5D-5L
Description	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.
Time Frame	12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Global Perceived Effect
Description	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.
Time Frame	12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6, 12, 18, and 24 months
Adverse Event Reporting Description	A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events. Detailed adverse event terms not provided in this report as the post-market device being studied was used on label and most of the events are unrelated. Additionally, considering the subject population being studied, no unexpected events were reported.
Arm/Group Title	Cooled Radiofrequency		Hyaluronic Acid Injection
Arm/Group Description	Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe		Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain
All Cause Mortality
	Cooled Radiofrequency		Hyaluronic Acid Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/89 (0%)		0/88 (0%)
Serious Adverse Events
	Cooled Radiofrequency		Hyaluronic Acid Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/89 (6.7%)		2/88 (2.3%)
Cardiac disorders
Cardiovascular	1/89 (1.1%)	1	0/88 (0%)	0
Gastrointestinal disorders
Gastrointestinal	1/89 (1.1%)	2	2/88 (2.3%)	2
General disorders
H.E.E.N.T	1/89 (1.1%)	1	0/88 (0%)	0
Other	1/89 (1.1%)	1	0/88 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal	1/89 (1.1%)	1	0/88 (0%)	0
Nervous system disorders
Neurological	1/89 (1.1%)	1	0/88 (0%)	0
Renal and urinary disorders
Genitourinary	0/89 (0%)	0	1/88 (1.1%)	1
Other (Not Including Serious) Adverse Events
	Cooled Radiofrequency		Hyaluronic Acid Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/89 (47.2%)		43/88 (48.9%)
Blood and lymphatic system disorders
Infection	1/89 (1.1%)	1	0/88 (0%)	0
Cardiac disorders
Cardiovascular	2/89 (2.2%)	2	1/88 (1.1%)	1
Endocrine disorders
Endocrine/Metabolic	2/89 (2.2%)	2	0/88 (0%)	0
Gastrointestinal disorders
Gastrointestinal	0/89 (0%)	0	2/88 (2.3%)	2
General disorders
Other	8/89 (9%)	11	10/88 (11.4%)	11
Musculoskeletal and connective tissue disorders
Musculoskeletal	41/89 (46.1%)	66	35/88 (39.8%)	46
Nervous system disorders
Neurological	2/89 (2.2%)	2	2/88 (2.3%)	2
Renal and urinary disorders
Genitourinary	1/89 (1.1%)	1	1/88 (1.1%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory	0/89 (0%)	0	1/88 (1.1%)	1
Skin and subcutaneous tissue disorders
Skin	2/89 (2.2%)	2	2/88 (2.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.