Status:
UNKNOWN
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With Hip OA Compared to Intra-articular Steroid Injections
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Rothman Institute Orthopaedics
Conditions:
Osteoarthritis, Hip
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This will be a multi-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (...
Detailed Description
This prospective, single-blinded randomized clinical trial investigates the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function ...
Eligibility Criteria
Inclusion
- Male or female subjects older than 18 years of age presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days (Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4)
- Relief of patients' typical hip pain symptoms after a positive diagnostic nerve block test and eligibility for cooled radiofrequency ablation of these same nerves
Exclusion
- Patients who have received any steroid injection in hip within the last 90 days
- Individuals who cannot consent for themselves such as children and subjects with impaired decision making
- Local infection at injection site or active systemic infection
- Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and CRFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
- Automated implantable cardioverter defibrillator with inability to utilize magnet for CRFA per treating cardiologist
- Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
- Allergy or severe renal impairment precluding iodinated contrast or magnevist injection despite standard premedication protocol
- Negative diagnostic nerve block tests
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04329884
Start Date
December 1 2019
End Date
January 1 2022
Last Update
April 1 2020
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02511