Cooled RF Lesion MRI Characteristics

Not Applicable

• Conditions: Hip Osteoarthritis; Arthritis, Degenerative; Arthritis;Lumbosacral; Sacroiliitis; Osteo Arthritis Knee
• Interventions: Device: Cooled radiofrequency ablation

• Registration Number: NCT03631030
• Lead Sponsor: International Spine, Pain and Performance Center

Brief Summary

This Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac (SI) region, hip and knee).

Detailed Description

This study will be a prospective, single-center, pilot study. Adult subjects over the age 21 diagnosed with chronic joint pain (≥ 3 months), scheduled to receive Radiofrequency denervation and meet the selection criteria are eligible to participate in this study. The specific targeted areas of interest in this study will include Cervical facet joints, Thoracic facet joints, Lumbar facet joints, Sacroiliac (SI) region, hip and knee.

The treating physician will follow Standard of Care treatment for all enrolled subjects. As illustrated in Figure 1, the study consists of a screening visit, a treatment visit and a follow up visit. All subjects receiving CRFA will receive an MRI 2 - 7 days after the CRFA procedure. Subjects receiving CRFA of the Sacroiliac Joint will also receive an MRI within 30 days prior to the CRFA procedure. The treating physician may also request an MRI be performed prior to the procedure for subjects receiving CRFA of other targeted areas. The point of enrollment for each subject is the time that they sign the Informed Consent Form.

MRI data will be reviewed by the radiologist on a per patient basis to confirm lesion characteristics. It is anticipated that 3-5 subjects per level will be needed to fully quantify lesion characteristics, however; enrollment will remain flexible for each targeted area based on real time review of MRI data.

Study Timeline

• Study Start: 2018-02-25
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age ≥ 21 years
2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
3. Must be clinically appropriate candidate to receive CRFA for treatment of chronic pain.
4. Willing and able to receive an MRI

Exclusion Criteria

1. Unable to receive an MRI (i.e. due to pacemaker or iron-based metal implant).
2. Unable to receive an MRI (i.e. iron-based metal implant).
3. Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14mm in diameter to limit the risk of skin burns.
4. Active joint infection or systemic or localized infection at the needle entry site (subject may be considered for inclusion once infection is resolved.)
5. Subject currently implanted with a pacemaker or defibrillator
6. In the event a pre-treatment MRI is obtained; trauma or injury occurring to the targeted area between the baseline MRI and CRFA treatment
7. Subject unwillingness or unable to comply with protocol requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cooled radiofrequency ablation	Cooled radiofrequency ablation	This is a single arm study. Patients who will be undergoing cooled radiofrequency ablation for the treatment of arthritis in the cervical facet joints, thoracic facet joints, lumbar facet joints, sacroiliac (SI) region, hip and knee.

Primary Outcome Measures

Name	Time	Method
Cooled radiofrequency ablation lesion size	MRI obtained between 2-7 days post-procedure.	Size in millimeters of cooled radiofrequency ablation lesion via MRI

Secondary Outcome Measures

Name	Time	Method
Pain relief	2-4 weeks post-procedure as compared to pre-procedure	Compare pre-procedure and post-procedure change in pain using the numerical pain rating scale with 0 being no pain and 10 being the worst possible pain.

Trial Locations

Locations (2)

International Spine, and Performance Center; 🇺🇸 Washington, District of Columbia, United States

International Spine, Pain and Performance Center; 🇺🇸 Arlington, Virginia, United States