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

NCT03647332 | Unknown FDA Device

• 1 other identifier: 2018Stolzenberg
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain

  Visual Analog Scale

  24 weeks following treatment

Study Arms (2)

Cooled RFA treatment

ACTIVE COMPARATOR

Procedure: Cooled RFA treatment

Steroid injection

ACTIVE COMPARATOR

Drug: Steroid Drug

Interventions

Cooled RFA treatment PROCEDURE

cooled radiofrequency ablation

Cooled RFA treatment

Steroid Drug DRUG

steroid injection

Steroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: July 5, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

US (1)