Trial Outcomes & Findings for Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain (NCT NCT02260869)

NCT ID: NCT02260869

Last Updated: 2022-04-26

Results Overview

A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level. Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable. A negative change in VAS means a reduction in pain level after 24-weeks of treatment.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2022-04-26

Participant Flow

Participant milestones

Measure	Cooled Radiofrequency Ablation Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe	Monopolar Radiofrequency Ablation Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
Overall Study STARTED	38	37
Overall Study COMPLETED	31	29
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Cooled Radiofrequency Ablation n=38 Participants Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe	Monopolar Radiofrequency Ablation n=37 Participants Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)	Total n=75 Participants Total of all reporting groups
Age, Continuous	62.2 years STANDARD_DEVIATION 10.3 • n=38 Participants	56.8 years STANDARD_DEVIATION 12.3 • n=37 Participants	60.0 years STANDARD_DEVIATION 11.8 • n=75 Participants
Sex: Female, Male Female	27 Participants n=38 Participants	25 Participants n=37 Participants	52 Participants n=75 Participants
Sex: Female, Male Male	11 Participants n=38 Participants	12 Participants n=37 Participants	23 Participants n=75 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index	33.0 kg/m^2 STANDARD_DEVIATION 5.2 • n=38 Participants	31.9 kg/m^2 STANDARD_DEVIATION 4.6 • n=37 Participants	32.5 kg/m^2 STANDARD_DEVIATION 5.0 • n=75 Participants
Knee Pain VAS Score	74.4 mm STANDARD_DEVIATION 12.2 • n=38 Participants	73.0 mm STANDARD_DEVIATION 11.3 • n=37 Participants	73.7 mm STANDARD_DEVIATION 11.7 • n=75 Participants
Oxford Knee Score	19.9 oxford knee score STANDARD_DEVIATION 7.4 • n=38 Participants	17.7 oxford knee score STANDARD_DEVIATION 5.2 • n=37 Participants	18.8 oxford knee score STANDARD_DEVIATION 6.5 • n=75 Participants

PRIMARY outcome

Timeframe: 24 weeks

A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level.

Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable.

A negative change in VAS means a reduction in pain level after 24-weeks of treatment.

Outcome measures

Measure	Cooled Radiofrequency Ablation n=49 knees Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe	Monopolar Radiofrequency Ablation n=47 knees Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
Evidence of Change in Knee Pain	-40.7 mm Standard Deviation 26.8	-38.6 mm Standard Deviation 27.8

SECONDARY outcome

Timeframe: 24 weeks

Standard score system (Oxford Knee Score) was used to assess functional changes at 24 weeks of treatment relative to baseline. The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible.

Change in OKS = (OKS at 24 weeks) - (OKS at baseline) A positive Change in OKS indicates an improvement in extent of function.

Outcome measures

Measure	Cooled Radiofrequency Ablation n=49 knees Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe	Monopolar Radiofrequency Ablation n=47 knees Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
Evidence of Functional Changes	10.7 Oxford Knee Score Standard Deviation 9.1	12.7 Oxford Knee Score Standard Deviation 10.4

Adverse Events

Cooled Radiofrequency Ablation

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Monopolar Radiofrequency Ablation

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cooled Radiofrequency Ablation n=38 participants at risk Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe	Monopolar Radiofrequency Ablation n=37 participants at risk Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
Infections and infestations Pneumonia	2.6% 1/38 • Number of events 1 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	2.7% 1/37 • Number of events 1 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
Musculoskeletal and connective tissue disorders Broken Left Femur	2.6% 1/38 • Number of events 1 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	0.00% 0/37 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/38 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	2.7% 1/37 • Number of events 1 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
Renal and urinary disorders Acute kidney injury	0.00% 0/38 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	2.7% 1/37 • Number of events 1 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
Gastrointestinal disorders Worsening of reflux esophagitis	0.00% 0/38 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	2.7% 1/37 • Number of events 1 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.

Other adverse events

Measure	Cooled Radiofrequency Ablation n=38 participants at risk Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe	Monopolar Radiofrequency Ablation n=37 participants at risk Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
Musculoskeletal and connective tissue disorders Knee Pain or Swelling	15.8% 6/38 • Number of events 8 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	10.8% 4/37 • Number of events 4 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
Musculoskeletal and connective tissue disorders Other pain	7.9% 3/38 • Number of events 3 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	8.1% 3/37 • Number of events 3 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
Musculoskeletal and connective tissue disorders Bruised body parts	0.00% 0/38 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	5.4% 2/37 • Number of events 2 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
Infections and infestations Respiratory tract infections	18.4% 7/38 • Number of events 10 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	24.3% 9/37 • Number of events 12 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
Musculoskeletal and connective tissue disorders Muscular issues	5.3% 2/38 • Number of events 2 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.	5.4% 2/37 • Number of events 3 • Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.

Additional Information

David Cedeno

Lumbrera LLC

Phone: 3098266974

Email: dclumbrera@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place