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

Osteo Arthritis of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03647332
• Other study ID #: 2018Stolzenberg
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2017
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis of Hip
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Cooled RFA treatment
cooled radiofrequency ablation

Drug:
• Steroid Drug
steroid injection

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Visual Analog Scale	24 weeks following treatment