Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-02-21 @ 1:52 AM
Study NCT ID:
NCT02343003
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain
Sponsor:
Halyard Health
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: