NCT05490355

Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine if radiofrequency ablation plus steroid perineural injections at the knee or hip provide longer pain relief and better function to patients than the current standard of care, perineural steroid injections alone. This pilot study is a prospective two arm randomized trail, all participants will be recruited from the University of Texas Southwestern Medical Center (UTSW) outpatient orthopedic clinic. 40 participants (20 hip and 20 knee OA) will be enrolled into the standard of care arm (treated with steroid injections alone) and 40 participants (20 hip and 20 knee OA) will be enrolled into the investigational arm (treatment with a combination of radiofrequency ablation (RFA) plus steroid injections) for a total of 80 enrolled participants. All subjects will complete a function and pain assessment at the time of injection and three additional time points: 2 weeks, 3 months, and 6 months post injection. This study will use the same knee function questionnaire and frequency currently used in clinic per standard of care. In addition, all participant's surgical history and prior injection history will be reviewed via the Electronic Medical Record (EMR).

Conditions

• Osteoarthritis, Knee
• Osteoarthritis, Hip

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency Ablation (RFA)	RFA involves heating of periarticular nerves using continuous RFA (80-90C for 60-90 seconds) that results in electromodulation and denervation reducing pain. It can be done under fluoroscopy or CT guidance. CT guidance has additional benefit of better localization of the nerves, as opposed to simple bony landmarks used in fluoroscopy, since nerve branching variations are common and will be used in this study.
PROCEDURE	Perineural Steroid Injection	Perineural Steroid Injections involve CT guided injection of Local Anesthetic and Steroid into a nerve root of the spine to provide ongoing pain relief.

Timeline

• Start date: 2022-12-20
• Primary completion: 2023-01-28
• Completion: 2023-01-28
• First posted: 2022-08-05
• Last updated: 2024-09-25

Locations

1 site across 1 country: United States