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

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ClinicalTrials.gov Identifier: NCT03647332
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Osteo Arthritis of Hip Procedure: Cooled RFA treatment Drug: Steroid Drug Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cooled RFA treatment Procedure: Cooled RFA treatment
cooled radiofrequency ablation

Active Comparator: Steroid injection Drug: Steroid Drug
steroid injection




Primary Outcome Measures :
  1. Pain [ Time Frame: 24 weeks following treatment ]
    Visual Analog Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647332


Locations
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United States, Pennsylvania
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Tiffany Morrison    267-339-7818    tiffany.morrison@rothmaninstitute.com   
Sponsors and Collaborators
Rothman Institute Orthopaedics

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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03647332     History of Changes
Other Study ID Numbers: 2018Stolzenberg
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases