A 6-month, Double-blinded, Sham-controlled Clinical Trial Assessing the Clinical Usefulness of Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Efficacy Outcome
研究概览
简要总结
The purpose of this study is to assess how clinically useful and safe genicular nerve radiofrequency ablation is in people with chronic pain after total knee arthroplasty performed for osteoarthritis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible individuals over 18 years of age in general good health apart from their chronic knee pain
- •At least one year post-TKA
- •Report of chronic knee pain classified using a standard question about the presence of "pain, aching, or stiffness in the knee on most days for at least one month during the prior 6 months"
- •In an unacceptable symptom state classified using a validated question: "Think about all consequences of your arthroplasty in the last week. If you were to remain for the rest of your life as you were during the last week, would the current state be acceptable or unacceptable for you?"
- •Willingness to complete all the study procedures, including a daily pain NRS, AE, and medication usage questions via daily notification
- •Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed
排除标准
- •Pregnant women, breastfeeding women, and women who are not post-menopausal (defined at 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
- •Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control as outlined in Section 5.3.1 during the study period
- •Significant evidence of infection within the knee or radiographic evidence of prosthesis loosening as defined by the orthopedic surgeon
- •Individuals with pain exclusively located in the posterior knee, evaluated systematically using a validated Knee Pain Map
- •Individuals who do not achieve a 70% pain reduction following the initial prognostic block, consistent with clinical practice
- •Participation in a clinical research trial that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 30 days prior to the Screening Visit, or planned participation in any such trial
- •Use of anticoagulants and inability to withhold for three days prior to the study RFA procedure with clearance by the prescribing physician
- •Other conditions that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
研究组 & 干预措施
Radiofrequency Ablation
Patient undergoing genicular nerve radiofrequency ablation.
干预措施: Radiofrequency Ablation (Device)
Sham
Patient undergoing sham.
干预措施: Sham (Device)
结局指标
主要结局
Efficacy Outcome
时间窗: 3 months
\<5 number needed to treat to achieve a patient-acceptable symptom state. Patient acceptable symptom state will be defined with the following question: "Think about all consequences of your arthroplasty in the last week. If you were to remain for the rest of your life as you were last week, would the current state be acceptable or unacceptable for you?"61 Primary efficacy measure will be whether a participant considers themselves in an acceptable symptom state at the 3-month visit after the intervention. A \<5 number is needed to treat to achieve a patient-acceptable symptom state.
Acceptability by actively treated participants Outcome
时间窗: 3 months
Our a priori decision rule for acceptability of RFA will be that 50% of the actively treated participants respond affirmatively at the 3-month visit: "Would you recommend the treatment used in this study to someone in a similar situation with knee pain after a knee replacement?"
Safety Outcome
时间窗: 6 months
\<2 serious adverse events among 20 actively treated participants. After enrollment, participants will complete training regarding the daily notification for daily adverse event monitoring. During the study, participants will be automatically prompted daily to report adverse events on their mobile device or home computer. If a participant does not complete adverse event monitoring daily, a member of the study team will contact them to troubleshoot. Additionally, a more thorough examination of patient safety will be conducted during the clinical exam in the 1-, 3-, and 6-month follow-up visits. Prosthesis safety will be assessed with skyline, lateral, and anteroposterior radiographs (e.g. aseptic loosening, osteolysis) at baseline and 6 months69. Serious adverse events will be consistent with our institution's IRB definitions and with a definition of serious adverse drug experience in FDA 21 CFR 312.32(a).
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(1-, 3-, and 6-month visits)
- Physical Activity Scale for the Elderly (PASE)(1-, 3-, and 6-month visits)
- Walk Test(1-, 3-, and 6-month visits)
- Incidence of Pain Medication use(1-, 3-, and 6-month visits)
- Quality of Life Measured using Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS QOL)(1-, 3-, and 6-month visits)
- Pain Number Rating Score (NRS)(6 months)
- Daily Step Count(1-, 3-, and 6-month visits)
- Quality of Life Measured using Patient Reported Outcome Measurement Information System (PROMIS) Global 10(1-, 3-, and 6-month visits)
- Chair Stand Test(1-, 3-, and 6-month visits)
- Gait Analysis(3 months)
研究者
Timothy McAlindon
Professor
University of Massachusetts, Worcester