Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Hip Functional score at baseline (pre-procedure)
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1 & 2 or 3)
- •Males or females age 18 to 100 years
- •Osteoarthritis of the knee Kellgren-Lawrence grade 3-4 OR
- •Osteoarthritis of the hip Tonnis grades 2 or higher
Exclusion Criteria
- •History of knee or hip replacement
- •History of intra-articular steroid injections within the past 6 weeks
- •Active infection
Outcomes
Primary Outcomes
Hip Functional score at baseline (pre-procedure)
Time Frame: 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.
Hip Functional score at 6 months post procedure
Time Frame: 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.
Hip Functional score at 3 months post procedure
Time Frame: 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.
Knee Functional score as measured by standard of care questionnaire for knee OA at 3 months post procedure
Time Frame: 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.
Knee Functional score as measured by standard of care questionnaire for knee OA at 6 months post procedure
Time Frame: 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.
Knee Functional score as measured by standard of care questionnaire for knee OA at baseline (pre-procedure)
Time Frame: 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.
Hip Functional score at 2 weeks post procedure
Time Frame: 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.
Knee Functional score as measured by standard of care questionnaire for knee OA at 2 weeks post procedure
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Avneesh Chhabra
Chief, Musculoskeletal Radiology
University of Texas Southwestern Medical Center