Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections

Not Applicable

• Conditions: Osteo Arthritis of Hip
• Interventions: Drug: Steroid Drug; Procedure: Cooled RFA treatment

• Registration Number: NCT03647332
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

This will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled RFA for the treatment of OA hip pain and function in subjects treated with cooled RFA compared with standard of care intra-articular steroid injections

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-05
• Status Verified: 2018-08
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Study First Posted: 2018-08-27
• Last Update Posted: 2018-08-27
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Subjects presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days will be targeted. Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4
• Not an operative candidate as per RI joint replacement surgeon OR
• Subjects who do not desire joint replacement surgery after consultation with RI joint replacement surgeon
• Male or non-pregnant female older than 18 years of age
• willing and able to sign the IRB-approved informed consent document.

Exclusion Criteria

• Any steroid injection in hip within 90 days
• Local infection at injection site or active systemic infection
• Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and RFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
• AICD with inability to utilize magnet for RFA 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 iodionated contrast or magnavist injection despite standard premedication protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid injection	Steroid Drug	-
Cooled RFA treatment	Cooled RFA treatment	-

Primary Outcome Measures

Name	Time	Method
Pain	24 weeks following treatment	Visual Analog Scale

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States