Evaluation of the Efficacy of Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale
研究概览
简要总结
The purpose of this study is to evaluate the changes in clinical and imaging outcomes following arthroscopic treatment of chondral lesion(s) by Radiofrequency-Based debridement or Mechanical Debridement in subjects 18-50 years of age.
详细描述
This is a non-inferiority, prospective, single blinded, randomized, single-center study design with enrollment of 82 randomized subjects (to assure 70 subjects complete the study). The sample size of 82 participants was calculated from a power analysis. The study was powered to detect at least a seven point change in KOOS pain score based on achieving 80% statistical power to detect a non-inferiority margin. Study duration will be until the last subject enrolled reaches 52 weeks post-operative.
The 82 randomized subjects will be randomized at a 1:1 ratio into the Werewolf Coblation wand treatment group or mechanical debridement treatment group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent arthroscopy, the blinded assignment will be revealed to the subject.
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
Study subject will not be made aware of the treatment received until after completion of the research study.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Given written informed consent on the IRB approved consent form specific to the study, prior to study participation
- •18-50 years old
- •Male or Female
- •Suspected chondral damage in the following locations where debridement is indicated:
- •Medial femoral condyle
- •Lateral femoral condyle
- •< 30% joint space narrowing as seen on x-ray (merchant view, AP and PA Rosenberg)
- •1 or more chondral lesion(s) as noted on MRI
排除标准
- •Previous chondral treatment in the same compartment (prior debridement and lavage performed more than three months prior to baseline are acceptable)
- •Focal chondral defect indicated for concomitant procedures (i.e., microfracture, ACI, MACI, OATs)
- •Concomitant procedures that are not allowed:
- •Lateral retinacular release
- •Excision of osteophytes
- •Subchondroplasty
- •Manipulation under anesthesia
- •ACL reconstruction
- •Quad tendon repair
- •Patellar tendon repair
- •Patellar tendon debridement
- •Multiligament reconstruction
- •Pregnant and/or intending to become pregnant during this study period
结局指标
主要结局
Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale
时间窗: change from baseline at week 52 post-op
The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
次要结局
- Visual Analogue Scale (VAS)(change from baseline at week 52 post-op)
- International Knee Documentation Committee (IKDC) subjective knee evaluation(change from baseline at week 52 post-op)
- International Knee Documentation Committee (IKDC) objective knee(change from baseline at week 52 post-op)
- Marx Activity Rating Scale (MARS)(change from baseline at week 52 post-op)
- Work Productivity and Activity Impairment (WPAI V2.0)(change from 1 week post op to 6 weeks post-op)
- MRI(change from baseline at week 52 post-op)
研究者
Christopher Kaeding
Professor - Clinical
Ohio State University