NL-OMON52931已完成不适用
Prospective Post-Market Data Collection on Patients with Bone Marrow Lesions in the Knee Treated with Subchondroplasty procedure - SCP-EMEA-01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 ar-ticular surface of the joint confirmed on T2 weighted fat-suppressed or
- •Proton Density MR Imaging by presence of white signal
- •- Index knee alignment is defined radiographically as one of the following:
- •Neutral, <= 6° mechanical varus, or <= 6° mechanical valgus
- •- A KOOS Pain subscale total score < 70
- •- Is refractory to conservative non-surgical management of BML:
- •- having failed 2 or more of the following: hyaluronic acid (HA) injection,
- •corti-costeroid injection, non-steroidal anti-inflammatory drugs (NSAIDs),
- •physical therapy, bracing, or minimal surgical intervention (e.g. arthroscopy,
- •debride-ment/chondroplasty, and/or loose body removal)
- •- and diagnosis of BML is >= 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
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 osteoarthritis (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 OA1
- •- 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, , 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
研究者
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