A Prospective, Double Blinded, Multicenter, Randomized, Controlled Trial to Evaluate Mechanical Debridement vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 148
- 试验地点
- 7
- 主要终点
- Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative
研究概览
简要总结
The purpose of this study is to evaluate changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age.
详细描述
This is a non-inferiority, prospective, double blinded, multi-center, randomized, controlled, adaptive study design with enrollment of 82 randomized subjects at up to 13 study sites. Study duration will be until the last subject enrolled reaches 104 weeks post-operative.
The study will be comprised of two parts:
Part I: Part I will require all Investigators perform 1 to 3 procedures using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Investigators must be qualified by training to perform procedures prior to use of either study device. This purpose of Part I will be to minimize variability with the recommended directions for use established in the instructions for use (IFU). Part I subjects will be followed per protocol follow-up requirements, and will be included in the safety population only. These subjects will be additive (to the safety population) to the 82 randomized subjects planned as part of the primary evaluation in Part II.
Part II: Part II will consist of 82 randomized subjects. Each Investigator may initiate enrollment of subjects in this part of the study following completion of Part I requirements. The Part II study implements a randomized adaptive study design, whereby an interim analysis will be conducted for sample size re-assessment. There is no intention of reducing the sample size as a result of this interim analysis; however, the sample size may be increased to either establish the non-inferiority and/or may be increased sufficiently to establish superiority depending on the results of the interim analysis.
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
- Double (Participant, 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
- •Subjects MUST meet ALL of the following criteria to be included in the study:
- •Given written informed consent on the IRB/REB approved Consent Form specific to the study, prior to study participation
- •Is male or non pregnant female ≥ eighteen (18) years of age
- •MRI within 9 months of enrollment into this study confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy (as determined by the Investigator)
- •Must present with pain in the index knee of moderate or severe (> 30 mm) as measured by the VAS
- •Must be able to understand English (written and oral)
- •Must be available to come to all study related visits and is physically and mentally willing and able to comply with all post-operative evaluations
- •Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
- •Intra-operative Inclusion Criteria
- •Subjects MUST meet ALL of the following criteria to be included in the study:
- •1. Arthroscopic confirmation of a lesion requiring treatment meeting the following parameters:
- •Single, treatable chondral lesion, localized to the medial femoral condyle,
- •ICRS Grade 2 with widely displaceable fibrillation or flaps or Grade 3A,
- •< 4cm2 in size
排除标准
- •Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
- •Body Mass Index (BMI) > 40 or index joint pain is due to BMI (as determined by Investigator)
- •Requires bilateral knee surgery
- •Any of the following conditions:
- •active joint infections
- •is immunocompromised, has Sickle Cell disease, has a primary bone disease (e.g., Paget's disease) or disorders that may adversely affect the healing process, or is terminally ill
- •inflammatory rheumatoid arthritis or other systemic inflammatory arthritis (i.e., gout)
- •metastatic and/or neoplastic disease
- •infectious, highly communicable diseases (e.g., active tuberculosis or active hepatitis)
- •coagulation disorder or patient is receiving anti-coagulants
- •documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within 12 months of enrollment into this study
- •diagnosed with a behavioral condition which could affect their ability to accurately comply with the study (e.g. developmental delay, attention deficit disorder, and autism)
- •Any of the following conditions in the index limb or joint:
- •Grade III or greater osteoarthritis as determined by AP radiograph (Kellgren-Lawrence classification)
- •systemic steroid therapy or steroid intra-articular therapy within 4 weeks of enrollment into this study
- •intra-articular viscosupplementation within 3 months of enrollment into this study
- •osteomyelitis, septicemia, or other infections that may spread to other areas of the body
- •fractures, osteocysts or osteolysis
- •recurrent patellar instability (e.g., subluxation or dislocation)
- •severe Varus or Valgus knee deformities (as determined by Investigator)
- •symptomatic tear of the lateral meniscus
- •avascular necrosis
- •synovial disorders (e.g., pigmented villanodular synovitis)
- •previous total or partial meniscectomy
- •requires reconstruction or replacement of medial or lateral meniscus
- •knee instability, malalignment, or patellar tracking dysfunction
- •prior treatment for cartilage repair, including but not limited to ACI, Mosaicplasty and/or marrow stimulation procedures
- •prior knee tendon and/or ligament repair or patellar surgery within 6 months of enrollment into this study
- •Any of the following conditions in the contralateral limb or joint:
- •greater than minimal abnormality as shown by clinical exam and/or imaging
- •scheduled or to be scheduled for surgery over the course of this study
- •involvement causing abnormal ambulation and non-compliance with post-operative rehabilitation guideline
- •The subject has implanted metallic devices (insulin pumps, nerve stimulators, etc), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the knee
- •The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the index knee
- •Receiving prescription narcotic pain medication for conditions unrelated to the index knee condition
- •Cardiac pacemaker or other electronic implant(s)
- •Pregnant and/or intending to become pregnant during this study period
- •Participated in a clinical study within 30 days of enrollment into this study, or who is currently participating in another clinical study.
- •Is a prisoner, or is known or suspected to be transient
- •Is involved with Worker's Compensation unrelated to the index knee
- •Is involved with health-related litigation
- •Intra-operative Exclusion Criteria
- •Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
- •Has more than 1 chondral lesion requiring treatment
- •Requires concomitant procedures (i.e., anterior cruciate ligament repair, high tibial osteotomy), excluding partial medial meniscectomy
- •Has a medial meniscal tear not requiring treatment
- •Has a medial meniscal tear requiring a procedure other than partial meniscectomy
- •Has a lateral meniscal tear requiring treatment
研究组 & 干预措施
Mechanical Debridement
Mechanical shaver removes areas of damaged tissue
干预措施: Mechanical Debridement (Device)
RF-based Debridement
Electrical energy removes areas of damaged tissue (Coblation®)
干预措施: RF-Based Debridement (Device)
结局指标
主要结局
Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative
时间窗: Postop Week 52
The scores of 5 subscales of KOOS (i.e., Pain, other Symptoms, Function in daily living \[ADL\], Function in Sport and Recreation \[Sport/Rec\] and knee related Quality of Life \[QoL\]) at Baseline, Week 52 and change from Baseline were summarized descriptively by treatment group. The average of KOOS subscale scores was considered as the primary endpoint. For any subject if the value of effectiveness parameter was missing at Week 52 then it was imputed by last observed post-Baseline value (LOCF method). Each subscale response is based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). Each subscale score is calculated independently. A score of 100 indicated no problems and a score of 0 indicated extreme problems. KOOS subscale score = 100 - (mean of the observed items within the subscale x100 / 4)
次要结局
- Subject Satisfaction Postoperatively at Weeks 52 and 104(Postop Weeks 52 and 104/ET)
- Change in Visual Analog Scale (VAS) Scores From Baseline(Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET)
- Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)(Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET)
- Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments(Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ET)
- Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation(Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET)
- Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation(Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET)
- Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation(Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET)
- Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.(Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/Early Termination (ET))
- Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation(Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET)
- Change in KOOS Scores From Baseline(Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET)
- Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score(Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET)
- Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score(Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET)
- Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)(Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET)