Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Hip Functional score at baseline (pre-procedure)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •History of knee or hip replacement
- •History of intra-articular steroid injections within the past 6 weeks
- •Active infection
结局指标
主要结局
Hip Functional score at baseline (pre-procedure)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Avneesh Chhabra
Chief, Musculoskeletal Radiology
University of Texas Southwestern Medical Center