Recruiting

Cooled Radiofrequency vs. Intra-articular Steroid

Sponsor:

Rothman Institute Orthopaedics

Code:

NCT03647332

Conditions

Osteo Arthritis of Hip

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cooled RFA treatment

Steroid Drug

Study Details

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

Study ID

NCT03647332

Start date

Jul 5, 2017

Status verified date

Aug, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cooled RFA treatment

active comparator: Steroid injection

Interventions

Cooled RFA treatment

cooled radiofrequency ablation

Steroid Drug

steroid injection

Primary outcome measure

  • Pain [ Time Frame: 24 weeks following treatment ]

Central Contacts and Locations

Locations

Rothman Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Tiffany Morrison

267-339-7818tiffany.morrison@rothmaninstitute.com

More Information

Sponsor

Rothman Institute Orthopaedics

Last update posted

Aug 27, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rothman Institute Orthopaedics on 2018-08-27.