An interventional study of Radiofrequency Ablation (RFA) and Perineural Steroid Injection in Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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).
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 1 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Inclusion Criteria: (1 \& 2 or 3)
Exclusion Criteria:
Participants assigned to this study arm will receive only Perineural Steroid Injections per clinical standards. Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.
Procedure: Perineural Steroid Injection
Participants assigned to this study arm will receive Perineural Steroid Injections plus Radiofrequency Ablation per clinical standards. Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.
Procedure: Radiofrequency Ablation (RFA) · Procedure: Perineural Steroid Injection
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.
Perineural Steroid Injections involve CT guided injection of Local Anesthetic and Steroid into a nerve root of the spine to provide ongoing pain relief.
Hip Functional score at baseline (pre-procedure)
Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at baseline (pre-procedure). Possible scores range from 1-100, where lower scores indicate worse function.
Time frame: Baseline (Pre-Procedure)
Hip Functional score at 2 weeks post procedure
Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 2 weeks post procedure. Possible scores range from 1-100, where lower scores indicate worse function.
Time frame: 2 weeks post procedure
Hip Functional score at 3 months post procedure
Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 3 months post procedure. Possible scores range from 1-100, where lower scores indicate worse function.
Time frame: 3 months post procedure
Hip Functional score at 6 months post procedure
Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 6 months post procedure. Possible scores range from 1-100, where lower scores indicate worse function.
Time frame: 6 months post procedure
Knee Functional score as measured by standard of care questionnaire for knee OA at baseline (pre-procedure)
Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at baseline (pre-procedure). Possible scores range from 1-100, where higher scores indicate worse function.
Time frame: Baseline (pre-procedure)
Knee Functional score as measured by standard of care questionnaire for knee OA at 2 weeks post procedure
Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 2 weeks post procedure. Possible scores range from 1-100, where higher scores indicate worse function.
Time frame: 2 weeks post procedure
Knee Functional score as measured by standard of care questionnaire for knee OA at 3 months post procedure
Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 3 months post procedure. Possible scores range from 1-100, where higher scores indicate worse function.
Time frame: 3 months post procedure
Knee Functional score as measured by standard of care questionnaire for knee OA at 6 months post procedure
Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 6 months post procedure. Possible scores range from 1-100, where higher scores indicate worse function.
Time frame: 6 months post procedure
Plan to share: No
This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center