Trial Outcomes & Findings for Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain (NCT NCT03381248)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

177 participants

Primary outcome timeframe

Baseline to 6 month study visit

Results posted on

2023-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Cooled Radiofrequency 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
0-6 Months STARTED	89	88
0-6 Months COMPLETED	76	82
0-6 Months NOT COMPLETED	13	6
6-12 Months STARTED	76	82
6-12 Months Received Crossover Treatment	0	68
6-12 Months COMPLETED	66	73
6-12 Months NOT COMPLETED	10	9
12 - 24 Months (Extension Study) STARTED	36	0
12 - 24 Months (Extension Study) COMPLETED	27	0
12 - 24 Months (Extension Study) NOT COMPLETED	9	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cooled Radiofrequency 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
0-6 Months Withdrawal by Subject	4	1
0-6 Months Lost to Follow-up	3	2
0-6 Months Lack of Efficacy	1	0
0-6 Months Adverse Event	1	0
0-6 Months Protocol Violation	2	1
0-6 Months Physician Decision	1	0
0-6 Months Planning another procedure	1	2
6-12 Months Withdrawal by Subject	1	3
6-12 Months Lost to Follow-up	0	2
6-12 Months Protocol Violation	3	2
6-12 Months Planning another procedure	6	2
12 - 24 Months (Extension Study) Withdrawal by Subject	3	0
12 - 24 Months (Extension Study) Lost to Follow-up	1	0
12 - 24 Months (Extension Study) Received another procedure	5	0

Baseline Characteristics

Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cooled Radiofrequency n=89 Participants 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 Injection n=88 Participants 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 n=177 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 10.7 • n=5 Participants	63.1 years STANDARD_DEVIATION 9.7 • n=7 Participants	63.2 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	54 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	80 Participants n=7 Participants	163 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	89 participants n=5 Participants	88 participants n=7 Participants	177 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 month study visit

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=76 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option n=82 Participants Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Numeric Rating Scale (NRS)	54 Participants	31 Participants	—

PRIMARY outcome

Timeframe: Baseline to 12 month study visit

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

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=89 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option n=88 Participants Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency n=68 Participants Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up.	78 Participants	48 Participants	38 Participants

SECONDARY outcome

Timeframe: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit

Population: 66 of the 89 originally-randomized study subjects in the Cooled Radiofrequency group completed this 12-month outcome measure. 62 of the originally-randomized 88 study subjects in the Hyaluronic Acid Injection group chose to crossover to receive Cooled Radiofrequency treatment and completed this 12-month outcome. 11 of the originally-randomized subjects in this group who elected not to crossover completed this 12-month outcome.

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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=66 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option n=11 Participants Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency n=62 Participants Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Numeric Rating Scale	43 Participants	10 Participants	40 Participants

SECONDARY outcome

Timeframe: Baseline to 6 month study visit

Population: The 'change from baseline' was unable to be calculated for one of the CRFA-randomized subjects as appropriate baseline measurements for this outcome measure were not collected. The comparison could not be performed for this subject. Therefore, the Overall Number of Participants Analyzed in this group is reduced by one.

The change in WOMAC score from baseline to 6 months. 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).

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=75 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option n=82 Participants Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	31.5 units on a scale Standard Deviation 23.0	14.8 units on a scale Standard Deviation 19.4	—

SECONDARY outcome

Timeframe: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit

Population: The 'change from baseline' was unable to be calculated for one of the CRFA-randomized subjects as appropriate baseline measurements for this outcome measure were not collected. The comparison could not be performed for this subject. Therefore, the Overall Number of Participants Analyzed in this group is reduced by one.

The change in WOMAC score from baseline to 12 months. 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).

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=65 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option n=11 Participants Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency n=62 Participants Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	30.7 units on a scale Standard Deviation 25.2	32.1 units on a scale Standard Deviation 18.3	18.1 units on a scale Standard Deviation 22.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 month study visit

Population: The 'change from baseline' was unable to be calculated for one of the CRFA-randomized subjects as appropriate baseline measurements for this outcome measure were not collected. The comparison could not be performed for this subject. Therefore, the Overall Number of Participants Analyzed in this group is reduced by one.

The change in measured EQ-5D-5L scale from baseline to 6 months. 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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=75 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option n=82 Participants Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
EQ-5D-5L	0.12 units on a scale Standard Deviation 0.14	0.06 units on a scale Standard Deviation 0.15	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit

Population: The 'change from baseline' was unable to be calculated for one of the CRFA-randomized subjects as appropriate baseline measurements for this outcome measure were not collected. The comparison could not be performed for this subject. Therefore, the Overall Number of Participants Analyzed in this group is reduced by one.

The change in measured EQ-5D-5L scale from baseline to 12 months. 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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=65 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option n=11 Participants Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency n=62 Participants Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
EQ-5D-5L	0.12 units on a scale Standard Deviation 0.14	0.14 units on a scale Standard Deviation 0.14	0.08 units on a scale Standard Deviation 0.15

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 month study visit

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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=76 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option n=82 Participants Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Global Perceived Effect	55 Participants	33 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit

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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=66 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option n=11 Participants Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency n=62 Participants Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Global Perceived Effect	42 Participants	8 Participants	39 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 18 month study visit

Population: 32 of the 36 study subjects who elected to participate in the CRFA extension phase of the study completed this 18-month outcome measure.

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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=32 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Numeric Rating Scale	22 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 month study visit

Population: 27 of the 36 study subjects who elected to participate in the CRFA extension phase of the study completed this 24-month outcome measure.

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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=27 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Numeric Rating Scale	17 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 18 month study visit

Population: Extension study subjects with 18-month data available for analysis for this outcome measure

The change in WOMAC score from baseline to 18 months. 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).

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=30 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	29.3 units on a scale Standard Deviation 25.3	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 month study visit

Population: Extension study subjects with 24-month data available for analysis for this outcome measure

The change in WOMAC score from baseline to 24 months. 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).

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=26 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	41.3 units on a scale Standard Deviation 29.9	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 18 month study visit

Population: Extension study subjects with 18-month data available for analysis for this outcome measure

The change in measured EQ-5D-5L scale from baseline to 18 months. 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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=30 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
EQ-5D-5L	0.15 units on a scale Standard Deviation 0.14	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 month study visit

Population: Extension study subjects with 18-month data available for analysis for this outcome measure

The change in measured EQ-5D-5L scale from baseline to 24 months. 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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=26 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
EQ-5D-5L	0.07 units on a scale Standard Deviation 0.14	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 18 month study visit

Population: Extension study subjects with 18-month data available for analysis for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=32 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Global Perceived Effect	24 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 month study visit

Population: Extension study subjects with 18-month data available for analysis for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=27 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Global Perceived Effect	17 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 month study visit to 24 month study visit

Safety: The proportion of subjects experiencing adverse events between 12 - 24 months (Extension)

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=36 Participants 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 Injection, Then Cooled Radiofrequency Crossover Option Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Qualifying study subjects will then have the option to crossover to receive CRFA at 3 months. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Safety: The Proportion of Subjects Experiencing Adverse Events Between 12 - 24 Months (Extension)	19 Participants	—	—

Adverse Events

Cooled Radiofrequency

Serious events: 13 serious events

Other events: 85 other events

Deaths: 0 deaths

Hyaluronic Acid Injection

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cooled Radiofrequency n=89 participants at risk 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 Injection n=88 participants at risk 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	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency n=68 participants at risk Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Cardiac disorders Cardiovascular	3.4% 3/89 • Number of events 3 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Gastrointestinal disorders Gastrointestinal	1.1% 1/89 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	2.3% 2/88 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Renal and urinary disorders Genitourinary	0.00% 0/89 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	1.1% 1/88 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
General disorders H.E.E.N.T	2.2% 2/89 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Musculoskeletal and connective tissue disorders Musculoskeletal	4.5% 4/89 • Number of events 4 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	1.5% 1/68 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Nervous system disorders Neurological	2.2% 2/89 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
General disorders Other	1.1% 1/89 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Blood and lymphatic system disorders Blood/Lymphatic	0.00% 0/89 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Endocrine disorders Endocrine/Metabolic	0.00% 0/89 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Musculoskeletal and connective tissue disorders Extremities	0.00% 0/89 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Respiratory, thoracic and mediastinal disorders Respiratory	0.00% 0/89 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Skin and subcutaneous tissue disorders Skin	0.00% 0/89 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).

Other adverse events

Other adverse events
Measure	Cooled Radiofrequency n=89 participants at risk 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 Injection n=88 participants at risk 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	Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency n=68 participants at risk Subjects initially randomized to the Control (Hyaluronic Acid) group who remained in significant pain at 6 months who chose to receive crossover Cooled Radiofrequency treatment. Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Blood and lymphatic system disorders Blood/Lymphatic/Infection	2.2% 2/89 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	1.5% 1/68 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Cardiac disorders Cardiovascular	4.5% 4/89 • Number of events 4 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	1.1% 1/88 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Endocrine disorders Endocrine/Metabolic	4.5% 4/89 • Number of events 4 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	1.5% 1/68 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Gastrointestinal disorders Gastrointestinal	2.2% 2/89 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	2.3% 2/88 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Renal and urinary disorders Genitourinary	1.1% 1/89 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	2.3% 2/88 • Number of events 6 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Musculoskeletal and connective tissue disorders Musculoskeletal	93.3% 83/89 • Number of events 127 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	43.2% 38/88 • Number of events 49 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	42.6% 29/68 • Number of events 50 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Nervous system disorders Neurological	9.0% 8/89 • Number of events 8 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	2.3% 2/88 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	4.4% 3/68 • Number of events 3 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Respiratory, thoracic and mediastinal disorders Respiratory	2.2% 2/89 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	1.1% 1/88 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/68 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Skin and subcutaneous tissue disorders Skin	3.4% 3/89 • Number of events 3 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	2.3% 2/88 • Number of events 3 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	1.5% 1/68 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
General disorders Other	14.6% 13/89 • Number of events 16 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	11.4% 10/88 • Number of events 11 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	13.2% 9/68 • Number of events 10 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).
Ear and labyrinth disorders H.E.E.N.T / Infection	2.2% 2/89 • Number of events 2 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	0.00% 0/88 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).	1.5% 1/68 • Number of events 1 • Total Study: Baseline to 24 months CRFA group includes all AEs from subjects randomized to and treated with Cooled Radiofrequency Ablation (from baseline to 24 months, including extension). HA group includes all AEs from subjects randomized to and treated with Hyaluronic Acid Injections (from baseline to 6 months) and AEs from subjects who did not receive crossover CRFA treatment (from 6 to 12 months). Crossover group includes all AEs experienced by HA subjects following receipt of crossover CRFA treatment (from 6 to 12 months).

Additional Information

David Curd

Avanos Medical

Phone: 470-448-5178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place