Prospective Post-Market Data Collection on Patients With Bone Marrow Lesions (BMLs) in the Knee Treated With the Subchondroplasty® (SCP®) Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 6
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale
研究概览
简要总结
This is a prospective, multi-center, post-market data collection study intended to collect data on the short- and long-term safety and performance of the SCP Procedure.
详细描述
Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure will be invited to participate. This study will enroll up to 95 patients across 4 investigative centers in Europe over a period of 12 months. The maximum study duration is expected to be 6 years.
Follow-up assessments will be conducted at 1 month, 3, 6, 12-months and 24-months post injection; and subjects will be asked questions regarding their pain and functioning to further understand long-term outcomes.
For all subjects at selected centers, a long standing X-ray and MRI at screening and either at 12 months or 24 months will be obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •At least 18 years of age at time of screening
- •Patient with BML(s) in one or both knees, as diagnosed by the treating physician, willing and eligible to undergo the SCP Procedure
- •One or more BML(s) of the tibial plateau and/or femoral condyle extending to the articular surface of the joint confirmed on T2 weighted fat-suppressed or fat-suppressed Proton Density MR Imaging by presence of white signal
- •Patient's index knee alignment, which is defined radiographically, must be one of the following: Neutral, 6 degree mechanical varus, or 6 degree mechanical valgus
- •Patient is refractory to conservative non-surgical management of BML:
- •Having failed 2 or more of the following: hyaluronic acid (HA) injection, corticosteroid injection, non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, bracing, or minimal surgical intervention (e.g. arthroscopy, debridement/chondroplasty, and/or loose body removal)
- •and diagnosis of BML is more than 3 months of the study treatment
- •Willing and able to comply with the study procedures
- •Signed an informed consent form approved by independent ethics committee (IEC)
排除标准
- •Existing acute or chronic infections at the surgical site
- •Bone in the index knee is non-viable or not capable of supporting and anchoring the implant.
- •Known systemic disorders or any systemic inflammatory condition (e.g. rheumatoid arthritis)
- •Acute traumatic injuries with open wounds close to the bone defect which are likely to become infected
- •Known metabolic bone disease, including disorders in calcium metabolism
- •Known immunologic abnormalities, including inflammatory bone disease
- •Has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years
- •Diagnosis of patella-femoral joint OA and/or primarily patella-femoral symptoms
- •BML caused by acute trauma less than 3 months prior to enrollment
- •Clinical and/or radiographic disease diagnosis of the index knee that includes any of the following:
- •Kellgren-Lawrence grade 4 Osteoarthritis (OA)
- •BML located at anterior cruciate ligament (ACL)/ posterior cruciate ligament (PCL) insertion
- •Any major or cartilage repair or alignment surgery (i.e. osteotomy, autograft, scaffold, marrow stimulation, debridement, all cell-based therapies, etc.) of the index knee within 12 months prior to enrollment
- •Pregnant at time of injection
- •Lactating at time of injection
- •Use of any investigational drug or device within 30 days prior to enrollment
- •Use of any investigational biologics within 30 days prior to enrollment
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale
时间窗: 12 months
Change in pain following SCP Procedure as measured by the KOOS pain subscale. The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, function in daily living, function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale.
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(2 year)
- Numerical Rating Scale (NRS) pain scale(2 year)
- EuroQol-5 Dimensions (EQ-5D)(2 year)
- Heath care utilization Questionnaire(2 year)
- Occurrence of Revisions(2 year)
- MRI location of injectate(12 months)
- Subject global satisfaction Questionnaire(2 year)
- Occurrence of Re-operations(2 year)
- Time to Re-operations(2 year)
- Time to Revisions(2 year)
- X-ray(12 months)
- MRI BML lesion size(12 months)
- MRI BML type(12 months)
- MRI Intraosseous vascularity(12 months)
- Adverse Events(2 year)