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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

Rothman Institute Orthopaedics logo

Rothman Institute Orthopaedics

Status

Unknown

Conditions

Osteo Arthritis of Hip

Treatments

Procedure: Cooled RFA treatment
Drug: Steroid Drug

Study type

Interventional

Funder types

Other

Identifiers

NCT03647332
2018Stolzenberg

Details and patient eligibility

About

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

Enrollment

86 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 2 patient groups

Cooled RFA treatment
Active Comparator group
Treatment:
Procedure: Cooled RFA treatment
Steroid injection
Active Comparator group
Treatment:
Drug: Steroid Drug

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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