NCT06705985尚未招募不适用
Treatment of Lateral Knee Joint Pain with Artificial Lateral Meniscus Prosthesis After Meniscectomy
ATRO Medical B.V.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年11月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The device subject to this clinical investigation has been developed for treating patients with a history of partial or total meniscectomy, who suffer from symptomatic unicompartmental pain in the meniscus-deficient knee: the post-meniscectomy pain syndrome. The intended purpose of the system is to replace the lateral native meniscus and its function after meniscectomy by distributing tibio-femoral loads and provide a clinically relevant reduction of pain and improvement of joint function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is aged 18 to 70 years (inclusive) at the time of screening
- •Has a history of partial or total meniscectomy
- •Has post-meniscectomy pain syndrome (defined as symptomatic unicompartmental pain in the meniscus- deficient knee without severe cartilage damage- Kellgren & Lawrence grade 3-4) in the lateral compartment as confirmed by patient history and MRI
- •Has a KOOS Pain of ≤ 75 at the time of screening
- •Failed conservative treatment options (non-operative treatments of the knee, i.e., self-management exercise programs, physical therapy, braces, pain medication, and intra-articular corticosteroids)
- •Has neutral alignment < ± 3° of the mechanical axis
- •Is willing to be implanted with the LMP System and to comply with instruction for use
- •Is able and willing to do the study required follow-up visits, questionnaires, X-rays, and MRI
- •Is able and willing to understand and sign the study Informed Consent Form
- •Is able to read and understand the national language of the country in which the clinical site is located
排除标准
- •Has progressed knee osteoarthritis, Kellgren & Lawrence grade 3- 4 in the lateral compartment
- •Has evidence of a modified Outerbridge Grade IV cartilage loss on the lateral tibial plateau or femoral condyle that potentially could contact the meniscus prosthesis
- •Has medial compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the medial compartment
- •Has a varus or valgus knee deformity of > 3°
- •Has a valgus alignment that is not passively correctable
- •Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL)
- •Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment
- •Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the patellar compartment
- •Had an ACL reconstruction performed < 9 months prior to surgery
- •Has a BMI > 35 at the time of screening
- •Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the lateral meniscus prosthesis
- •Has a knee flexion contracture > 10°
- •Has flexion < 90°
- •Had a knee alignment correction osteotomy < 9 months ago
- •Has insufficiency fractures or avascular necrosis of the lateral compartment
- •Has an active infection or tumor (local or systemic)
- •Has any type of knee joint inflammatory disease including Sjogren's syndrome
- •Has neuropathic knee osteoarthropathy, also known as Charcot joint
- •Has any medical condition that does not allow possible arthroscopy of the knee
- •Has neurological deficit (sensory, motor, or reflex)
- •Anticipates having another lower extremity surgery during the study period
- •Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
- •Has received any corticosteroid knee injections ≤ 3 months prior to surgery
- •Has proven osteoporosis
- •Is on immunostimulating or immunosuppressing agents
- •Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or study outcomes (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a noticeable limp)
- •Is a female who is lactating, expecting, or is intending to become pregnant during the study period
- •Is an active smoker at the time of surgery
- •Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
- •Has a condition or be in a situation that, in the Investigator's opinion, may confound the clinical investigation results, may risk the safety of the patient, or may interfere significantly with the subject's participation in the clinical investigation
结局指标
主要结局
Adverse events
时间窗: 12 months after implantation.
Adverse events within 12 months after implantation.
Implant integrity
时间窗: 12 months after implantation.
Assessed by MRI.
次要结局
- KOOS(24 months.)
- Lysholm(24 months.)
- OKS(24 months.)
- EQ-5D-5L(24 months.)
- WORQ(24 months.)
- SF-36(24 months.)
- Likert - Patient satisfaction(24 months.)
- Tegner Activity Scale(24 months.)
- IKDC Knee Examination Form(24 months.)
- Knee X-ray (weight-bearing)(24 months.)
- Knee X-ray (weight-bearing, long-leg)(24 months.)
- Knee X-ray (non-weight-bearing, supine)(24 months.)
- Knee MRI (non-weight-bearing)(24 months.)
研究者
研究点 (1)
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