Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain
This study is designed to:
- Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and
- Confirm the safety of Coolief when used to perform radiofrequency lesions of the genicular nerves in subjects to manage knee pain compared to safety of corticosteroid injection
|Osteoarthritis of the Knee||Device: Cooled Radiofrequency Drug: Corticosteroid injection|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective, Multi-Center, RCT Evaluating the Safety and Effectiveness of Coolief™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain|
- Numeric Rating Scale (NRS) [ Time Frame: baseline and 6-months ]The proportion of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS)
- Safety: Proportion of subjects experiencing adverse events through final follow up. [ Time Frame: baseline, 6-months, and 12-months ]Safety Endpoint: Proportion of subjects experiencing adverse events through final follow up.
- Numeric Rating Scale [ Time Frame: baseline and 12-months ]The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months.
- Oxford Knee Score [ Time Frame: baseline, 6-months, and 12-months ]Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months.
- Global Perceived Effect Score [ Time Frame: 6-months and 12-months ]Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months.
- Medication Usage [ Time Frame: baseline, 6-months, and 12-months ]Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.
|Actual Study Start Date:||January 2015|
|Study Completion Date:||March 16, 2017|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Cooled radiofrequency
Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain
Device: Cooled Radiofrequency
Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Other Name: Coolief
Active Comparator: Corticosteroid injection
Corticosteroid injections will be administered to study subjects' knees to reduce knee pain
Drug: Corticosteroid injection
Delivery of corticosteroid into knee by injection with needle to reduce knee pain
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects having knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Coolief system compared to subjects receiving corticosteroid injection. A total of approximately 144 subjects will be enrolled into this study with subjects undergoing either radiofrequency neurotomy or corticosteroid injection in a 1:1 randomization scheme. Follow up will be conducted for a total of 12 months post Coolief procedure with the primary endpoint being completed at month 6. Subjects randomized to the comparison (corticosteroid) group will have the option to cross over to the neurotomy group after completing the 6 month endpoint assessment. They would then be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups in order to determine success.
Primary Effectiveness Endpoint:
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS scale at 6 Months.
Primary Safety Endpoint:
The proportion of subjects experiencing adverse events through final follow up.
Secondary Effectiveness Endpoints:
- The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months.
- Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months.
Tertiary Effectiveness Endpoint:
Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months.
Quaternary Effectiveness Endpoint:
Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.
In addition, exploratory analyses of health economic indicators may be performed.
Subjects will participate in the study for up to 13 months (2 week roll-in period + treatment visit + 12 month follow up), except for subjects who participate in the optional crossover group. These crossover subjects will be on study for up to 15 months (2 week roll-in + treatment + 6 month follow-up and crossover + 6 month follow up). Enrollment is anticipated to take approximately 6-8 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02343003
|United States, Arizona|
|Valley Anesthesiology Consultants - Estrella|
|Phoenix, Arizona, United States, 85037|
|Valley Anesthesiology Consultants/Valley Pain Consultants|
|Scottsdale, Arizona, United States, 85254|
|United States, California|
|Orthopedic Pain Specialists|
|Santa Monica, California, United States, 90403|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Minnesota|
|MAPS Applied Research Center, Inc.|
|Maple Grove, Minnesota, United States, 55369|
|United States, New York|
|Ainsworth Institute of Pain Management|
|New York, New York, United States, 10022|
|United States, North Carolina|
|Center for Clinical Research|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Carolina|
|Piedmont Comprehensive Pain Management|
|Greenville, South Carolina, United States, 29622|
|United States, Virginia|
|Virginia iSpine Physicians|
|Richmond, Virginia, United States, 23235|
|United States, Wisconsin|
|Advanced Pain Management|
|Greenfield, Wisconsin, United States, 53221|
|Study Director:||David T Curd, MS||Halyard Health, Inc.|