A Prospective, Multi-center, Randomized, Single Blind Clinical Trial Comparing COOLIEF* Cooled Radiofrequency to Conventional Radiofrequency Ablation of the Genicular Nerves in the Management of Knee Pain in an Osteoarthritic Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 13
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
This study is being performed to assess the relative effectiveness of genicular nerve ablation with the COOLIEF* Cooled Radiofrequency probe to manage moderate to severe knee pain in patients with osteoarthritis (OA) of the knee when compared to radiofrequency ablation using a Standard Radiofrequency probe.
详细描述
This is a prospective, multi-center, randomized, single-blind comparison study examining the outcomes of subjects with osteoarthritic knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with either Cooled Radiofrequency Ablation (CRFA) or Conventional (Standard) Radiofrequency Ablation (SRFA). Approximately 148 participants from up to 15 sites will be enrolled into this study, with subjects undergoing either CRFA or SRFA in a 1:1 randomization scheme. Follow-up will be conducted for 24 months post-treatment, with the primary endpoint being completed at month 12. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success.
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
- Single (Participant)
盲法说明
The study is a participant-blinded trial and deliberate action, utilizing a physical barrier, will be needed to ensure the blind remains intact.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years
- •Able to understand and personally sign and date the informed consent form
- •Able to complete outcome measures
- •Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
- •Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs])
- •Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
- •Pain on NRS ≥ 6 on an 11-point scale for the index knee
- •Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) grade 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
- •Analgesics including membrane stabilizers such as Neurontin (gabapentin) and antidepressants for pain, such as Cymbalta (duloxetine), must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the course of the study without approval of the investigator
- •Agree to see one physician (study physician) for knee pain during the study period
- •Subjects of child bearing potential must be willing to utilize double barrier contraceptive method
- •Willingness to comply with the requirements of this protocol for the full duration of the study (24 months regardless of effect of initial therapy)
排除标准
- •Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic inflammatory condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause knee pain
- •Evidence of neuropathic pain affecting the index knee
- •Previous or pending lower limb amputation
- •Intra-articular steroid injection into the index knee within 90 days from randomization
- •Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
- •Prior radiofrequency ablation of the genicular nerves of the index knee
- •Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
- •Clinically significant ligamentous laxity of the index knee
- •Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations
- •Body mass index (BMI) > 40 kg/m2
- •Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the risk of skin burns
- •Pending or active compensation claim, litigation, or disability remuneration (secondary gain)
- •Pregnant, nursing or intent of becoming pregnant during the study period
- •Chronic pain associated with significant psychosocial dysfunction
- •Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator
- •Allergies to any of the medications to be used during the procedures
- •Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
- •History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable
- •Identifiable anatomical variability that would materially alter the procedure as described in the protocol
- •Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse
- •Current prescribed opioid medications greater than 60 mg morphine equivalent daily opioid dose
- •Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
- •Subject currently implanted with pacemaker, stimulator or defibrillator
- •Participating in another clinical trial/investigation which included therapeutic treatment within 30 days prior to signing informed consent
- •Subject unwilling or unable to comply with follow up schedule, protocol requirements or procedures
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: 12 months
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals "worst pain". There are no sub-scales.
次要结局
- Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)(12 months)
- EQ-5D-5L(12 months)
- Global Perceived Effect (GPE)(12 months)
- Additional Interventions(12 months)