Back to resultsUse of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
Primary Purpose
Osteo Arthritis of Hip
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cooled RFA treatment
Steroid Drug
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis of Hip
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
Sites / Locations
- Rothman InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cooled RFA treatment
Steroid injection
Arm Description
Outcomes
Primary Outcome Measures
Pain
Visual Analog Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03647332
First Posted
August 23, 2018
Last Updated
August 23, 2018
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03647332
Brief Title
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
Official Title
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis of Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cooled RFA treatment
Arm Type
Active Comparator
Arm Title
Steroid injection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Cooled RFA treatment
Intervention Description
cooled radiofrequency ablation
Intervention Type
Drug
Intervention Name(s)
Steroid Drug
Intervention Description
steroid injection
Primary Outcome Measure Information:
Title
Pain
Description
Visual Analog Scale
Time Frame
24 weeks following treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Morrison
Phone
267-339-7818
Email
tiffany.morrison@rothmaninstitute.com
12. IPD Sharing Statement
Learn more about this trial
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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