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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03647332
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rothman Institute Orthopaedics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteo Arthritis of Hip

Arms & Interventions

Arms

Active Comparator: Cooled RFA treatment

Active Comparator: Steroid injection

Interventions

Procedure: - Cooled RFA treatment

cooled radiofrequency ablation

Drug: - Steroid Drug

steroid injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rothman Institute, Philadelphia, Pennsylvania

Status

Recruiting

Address

Rothman Institute

Philadelphia, Pennsylvania, 19107

Site Contact

Tiffany Morrison

[email protected]

267-339-7818

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