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

Not Applicable

Completed

Conditions: Osteoarthritis of the Knee

Interventions: Device: Cooled Radiofrequency
Drug: Corticosteroid injection

Registration Number: NCT02343003

Lead Sponsor: Halyard Health

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cooled radiofrequency	Cooled Radiofrequency	Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain
Corticosteroid injection	Corticosteroid injection	Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS)	6 months	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".
Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up.	6 months and 12 months	Safety Endpoint: Number of subjects experiencing adverse events through final follow up.

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale	12 months	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".
Oxford Knee Score	6 months and 12 months	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".

Trial Locations

Locations (11): Orthopedic Pain Specialists
🇺🇸
Santa Monica, California, United States
Drexel University
🇺🇸
Philadelphia, Pennsylvania, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Valley Anesthesiology Consultants/Valley Pain Consultants
🇺🇸
Scottsdale, Arizona, United States
Valley Anesthesiology Consultants - Estrella
🇺🇸
Phoenix, Arizona, United States
Virginia iSpine Physicians
🇺🇸
Richmond, Virginia, United States
Center for Clinical Research
🇺🇸
Winston-Salem, North Carolina, United States
MAPS Applied Research Center, Inc.
🇺🇸
Maple Grove, Minnesota, United States
Ainsworth Institute of Pain Management
🇺🇸
New York, New York, United States
Piedmont Comprehensive Pain Management
🇺🇸
Greenville, South Carolina, United States
Advanced Pain Management
🇺🇸
Greenfield, Wisconsin, United States