Trial Outcomes & Findings for Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain (NCT NCT02343003)

Results Overview

The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (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".

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

151 participants

Primary outcome timeframe

6 months

Results posted on

2019-05-13

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	Corticosteroid Injection Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
Overall Study STARTED	76	75
Overall Study COMPLETED	58	68
Overall Study NOT COMPLETED	18	7

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	Corticosteroid Injection Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
Overall Study Withdrawal by Subject	9	4
Overall Study Lost to Follow-up	5	1
Overall Study Protocol Violation	1	0
Overall Study Death	0	1
Overall Study exclusion criteria met	1	1
Overall Study terminated by sponsor	2	0

Baseline Characteristics

Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
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	Corticosteroid Injection n=75 Participants Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain	Total n=151 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=99 Participants	30 Participants n=107 Participants	75 Participants n=206 Participants
Age, Categorical >=65 years	31 Participants n=99 Participants	45 Participants n=107 Participants	76 Participants n=206 Participants
Age, Continuous	63 years STANDARD_DEVIATION 11.9 • n=99 Participants	66.1 years STANDARD_DEVIATION 13.1 • n=107 Participants	64.6 years STANDARD_DEVIATION 12.5 • n=206 Participants
Sex: Female, Male Female	50 Participants n=99 Participants	49 Participants n=107 Participants	99 Participants n=206 Participants
Sex: Female, Male Male	26 Participants n=99 Participants	26 Participants n=107 Participants	52 Participants n=206 Participants
Region of Enrollment United States	76 participants n=99 Participants	75 participants n=107 Participants	151 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 68 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome.

The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (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".

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=58 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	Corticosteroid Injection n=68 Participants Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
Numeric Rating Scale (NRS)	43 Participants	11 Participants

PRIMARY outcome

Timeframe: 6 months and 12 months

Safety Endpoint: Number of subjects experiencing adverse events through final follow up.

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	Corticosteroid Injection n=75 Participants Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up. 6 months post-intervention	34 Participants	31 Participants
Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up. 12 months post-intervention	12 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 months

Population: 52 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 12 month outcome. 4 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 12 month outcome.

The number of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months. 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".

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=52 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	Corticosteroid Injection n=4 Participants Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
Numeric Rating Scale	34 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: 58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 3/75 in Corticosteroid injection group completed.

Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months. The Oxford Knee Score is determined by a 12-question survey that measures knee function, and is scored on a scale that ranges from 0 - 48 points, with scores of 0 - 19 = "severe arthritis", 20 - 29 = "moderate to severe arthritis", 30 - 39 = "mild to moderate arthritis", and 40 - 48 = "satisfactory joint function".

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=58 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	Corticosteroid Injection n=67 Participants Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
Oxford Knee Score 6 months post-intervention	18.5 units on a scale Standard Deviation 9.9	5.7 units on a scale Standard Deviation 8.9
Oxford Knee Score 12 months post-intervention	17.3 units on a scale Standard Deviation 12	8.7 units on a scale Standard Deviation 9.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Population: 58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 4/75 in Corticosteroid injection group completed.

Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months. The study subjects' perception of treatment effect was reflected by the Global Perceived Effect (GPE). 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".

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=58 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	Corticosteroid Injection n=67 Participants Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
Subject Satisfaction - Number of Participants With a Global Perceived Effect Score of 5 or Greater 6 months post-intervention	53 Participants	16 Participants
Subject Satisfaction - Number of Participants With a Global Perceived Effect Score of 5 or Greater 12 months post-intervention	39 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Population: 17 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 25 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 17/76 in Cooled radiofrequency group and 2/75 in Corticosteroid injection group completed.

Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.

Outcome measures

Outcome measures
Measure	Cooled Radiofrequency n=17 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	Corticosteroid Injection n=25 Participants Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
Medication Usage 12 months post-intervention	1 milligrams Standard Deviation 10.3	2.5 milligrams Standard Deviation 17.7
Medication Usage 6 months post-intervention	2.4 milligrams Standard Deviation 8.3	-0.6 milligrams Standard Deviation 9.8

Adverse Events

Cooled Radiofrequency

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Corticosteroid Injection

Serious events: 9 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cooled Radiofrequency n=76 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	Corticosteroid Injection n=75 participants at risk Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
Respiratory, thoracic and mediastinal disorders respiratory	1.3% 1/76 • Number of events 3 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	0.00% 0/75 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Renal and urinary disorders urogenital	1.3% 1/76 • Number of events 1 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	1.3% 1/75 • Number of events 1 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Gastrointestinal disorders gastrointestinal	0.00% 0/76 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	4.0% 3/75 • Number of events 4 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
General disorders other	0.00% 0/76 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	2.7% 2/75 • Number of events 2 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Musculoskeletal and connective tissue disorders procedure	1.3% 1/76 • Number of events 1 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	1.3% 1/75 • Number of events 1 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Infections and infestations infection	1.3% 1/76 • Number of events 1 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	0.00% 0/75 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Cardiac disorders cardiovascular	0.00% 0/76 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	2.7% 2/75 • Number of events 2 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.

Other adverse events

Other adverse events
Measure	Cooled Radiofrequency n=76 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	Corticosteroid Injection n=75 participants at risk Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain
General disorders extremities	47.4% 36/76 • Number of events 46 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	24.0% 18/75 • Number of events 24 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Blood and lymphatic system disorders blood/lymphatic	0.00% 0/76 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	1.3% 1/75 • Number of events 1 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Endocrine disorders endocrine/metabolic	1.3% 1/76 • Number of events 1 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	1.3% 1/75 • Number of events 1 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Gastrointestinal disorders gastrointestinal	3.9% 3/76 • Number of events 3 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	2.7% 2/75 • Number of events 5 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
General disorders head, eyes, ears, nose, throat	1.3% 1/76 • Number of events 1 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	2.7% 2/75 • Number of events 2 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Musculoskeletal and connective tissue disorders musculoskeletal	10.5% 8/76 • Number of events 10 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	4.0% 3/75 • Number of events 5 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Nervous system disorders neurological	2.6% 2/76 • Number of events 2 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	1.3% 1/75 • Number of events 3 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Respiratory, thoracic and mediastinal disorders respiratory	0.00% 0/76 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	9.3% 7/75 • Number of events 7 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Skin and subcutaneous tissue disorders skin	2.6% 2/76 • Number of events 2 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	2.7% 2/75 • Number of events 2 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Renal and urinary disorders urogenital	0.00% 0/76 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	2.7% 2/75 • Number of events 2 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
General disorders other	5.3% 4/76 • Number of events 6 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.	8.0% 6/75 • Number of events 10 • 12 months A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.

Additional Information

David Curd

Halyard Health

Phone: 470-448-5178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place