NCT03696836终止不适用
Treatment of Medial Knee Joint Pain With the Trammpolin® Meniscus Prosthesis
ATRO Medical B.V.6 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年10月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Knee injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale
研究概览
简要总结
The AIR Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® meniscus prosthesis system.
详细描述
The Trammpolin® meniscus prosthesis is intended to replace the native medial meniscus to provide pain relief in the medial compartment of the knee joint, when this is caused by medial partial meniscectomy.
Patients who meet the inclusion/exclusion criteria and who are implanted with the Trammpolin® meniscus prosthesis will be followed for 2 years. The patient reported outcome measures for knee pain and function, and knee clinical condition by MRI and X-ray is assessed post-operative compared to pre-operative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has medial compartment joint pain with > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
- •Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score)
- •Is between age 30 and 65 years (inclusive) at the time of screening
- •Has neutral alignment ± 5° of the mechanical axis, i.e., the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine to the center of the ankle joint, as confirmed by X-ray
- •Is willing to be implanted with the Trammpolin® meniscus prosthesis.
- •Is able to do the study required follow up visits, questionnaires, X-rays, CT-scans, and MRI's
- •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 relevant clinical site is located
排除标准
- •Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy
- •Has evidence of a modified Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a Trammpolin® meniscus prosthesis (e.g., a focal lesion > 0.5 cm2 correlating to a circular defect of > 8 mm in diameter)
- •Has lateral compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the lateral compartment
- •Has a varus or valgus knee deformity of > 5° requiring a tibial or femoral osteotomy
- •Has a varus 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.
- •Compared to a normal knee, has obvious radiological evidence of medial femoral squaring, anatomical variance in the medial tibial plateau, or irregularly shaped cartilage surface
- •Had an ACL reconstruction performed < 9 months prior to surgery
- •Has a BMI > 32.5 at the time of screening
- •Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the Trammpolin® meniscus prosthesis
- •Has a knee flexion contracture > 10°
- •Has flexion < 90°
- •Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)
- •Has insufficiency fractures or avascular necrosis of the medial 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)
- •Is currently involved in another investigation of the lower extremity
- •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 chondrocalcinosis
- •Has proven osteoporosis
- •Is on immunostimulating or immunosuppressing agents
- •Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or KOOS (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
- •Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
- •Is a prisoner
- •Has a condition or be in a situation that, in the Investigator's opinion, may confound the study results, or may interfere significantly with the subject's participation in the study
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale
时间窗: 24 Months
Performance of the Trammpolin® meniscus prosthesis in improving pain
Trammpolin® meniscus prosthesis device related complications
时间窗: 24 Months
The nature and frequency of all adverse events observed during the study
次要结局
- KOOS Pain sub-scale(6 Weeks; 3, 6 and 12 Months)
- Overall KOOS scale(6 Weeks; 3, 6, 12 and 24 Months)
- Lysholm scale(6 Weeks; 3, 6, 12 and 24 Months)
- IKDC objective scale(6 Weeks; 3, 6, 12 and 24 Months)
- Knee X-ray(6 Weeks; 12 and 24 Months)
- Knee MRI(12 and 24 Months)
研究者
研究点 (6)
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