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

NCT ID: NCT03647332

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-05
• Study Completion Date: 2019-12-31

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

Conditions

Osteo Arthritis of Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cooled RFA treatment

Group Type: ACTIVE_COMPARATOR

Cooled RFA treatment

Intervention Type: PROCEDURE

cooled radiofrequency ablation

Steroid injection

Group Type: ACTIVE_COMPARATOR

Steroid Drug

Intervention Type: DRUG

steroid injection

Interventions

Cooled RFA treatment

cooled radiofrequency ablation

Intervention Type: PROCEDURE

Steroid Drug

steroid injection

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Tiffany Morrison

Role: primary

tiffany.morrison@rothmaninstitute.com

267-339-7818

Other Identifiers

2018Stolzenberg

Identifier Type: -

Identifier Source: org_study_id