Recruiting

Cooled Radiofrequency vs. Steroid Injections

Sponsor:

Brigham and Women's Hospital

Code:

NCT04329884

Conditions

Osteoarthritis, Hip

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cooled RFA treatment with COOLIEF* device

intra-articular corticosteroid injection

Study Details

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 (OA) hip pain and function in subjects treated with CRFA compared with standard of care intra-articular steroid injections

Conditions

Osteoarthritis, Hip

Study ID

NCT04329884

Start date

Dec 1, 2019

Status verified date

Mar, 2020

Completion date

Jan 1, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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)
2. 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 Criteria:

1. Patients who have received any steroid injection in hip within the last 90 days
2. Individuals who cannot consent for themselves such as children and subjects with impaired decision making
3. Local infection at injection site or active systemic infection
4. 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)
5. Automated implantable cardioverter defibrillator with inability to utilize magnet for CRFA per treating cardiologist
6. Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
7. Allergy or severe renal impairment precluding iodinated contrast or magnevist injection despite standard premedication protocol
8. Negative diagnostic nerve block tests

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intra-articular corticosteroid injections

The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. Radiology guidance will be used to guide needle placement within the affected hip to administer lidocaine and a corticosteroid intra-articularly.

active comparator: Cooled radiofrequency ablation

The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. The HALYARD\* COOLIEF\* SINERGY\* Cooled Radiofrequency Probe (sterile, single use) is inserted through a COOLIEF\* SINERGY\* Introducer used with fluoroscopy guidance in the AP view to visualize the hip joint and sensory nerve areas over the acetabulum (femoral) and ischium (obturator) where the cooled radiofrequency ablation will be applied to create a focal thermal lesion to encompass and denervate the targeted nerves.

Interventions

Cooled RFA treatment with COOLIEF* device

Patients who are randomized to receive CRFA will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.

intra-articular corticosteroid injection

Patients who are randomized to receive intra-articular corticosteroid injections will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.

Primary outcome measure

  • Change in visual analog scale (VAS) pain by 1.5 points [ Time Frame: up to 24 weeks +/- 2 weeks after either a hip injection or following CRFA treatment for hip OA pain. ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02511

Contacts

Principal Investigator:

Antonia F Chen, MD/ MBA

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Apr 1, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2020-04-01.