NCT05297175招募中不适用
Feasibility of the Trammpolin® Medial Meniscus Prosthesis Intended to Restore the Medial Meniscus Function to Provide Pain Relief After Meniscectomy
ATRO Medical B.V.3 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Performance of the Trammpolin® medial meniscus prosthesis
研究概览
简要总结
The AIR2 Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® medial meniscus prosthesis.
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® medial 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has medial compartment knee pain and had a medial partial or total meniscectomy > 6 months ago. The lack of meniscus tissue is confirmed by patient history and MRI
- •Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score)
- •Is between age 18 and 70 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® medial meniscus prosthesis
- •Is willing and able to comply to the clinical investigation required follow up visits, questionnaires, X-rays and MRI's
- •Is able and willing to understand and sign the clinical investigation 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 potentially 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® medial meniscus prosthesis
- •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 > 30 at the time of screening
- •Has a knee flexion contracture > 10°
- •Has a knee flexion < 90°
- •Had a previous High Tibial Osteotomy (HTO) < 1 year ago
- •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 clinical investigation period
- •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 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 clinical investigation period
- •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
研究组 & 干预措施
Single arm
Other
Implantation of a medial meniscus prosthesis in the medial knee compartment of a post medial meniscectomy knee.
干预措施: Trammpolin medial meniscus prosthesis (Device)
结局指标
主要结局
Performance of the Trammpolin® medial meniscus prosthesis
时间窗: 24 months
Performance of the Trammpolin® medial meniscus prosthesis in improving pain as assessed by the Knee Osteoarthritis and injury Outcome Score (KOOS) Pain Sub-scale at 24 months post-operative compared to baseline (pre-operative) The minimum value is 0 and maximum value is 100, a score of 100 is being no pain and the highest attainable score
次要结局
- Work, Osteoarthritis or joint-Replacement Questionnaire (WORQ)(at 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Knee Osteoarthritis and injury Outcome Score (KOOS) overall(at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative).)
- PAIN Visual Analog Scale (VAS)(at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative)
- Lysholm Knee Scoring Scale(at 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Knee X-ray (weight-bearing)(12 months)
- Safety of the Trammpolin® medial meniscus prosthesis(6 weeks, 3 months, 6 months, 12 months and 24 months)
- Biopsy of synovium and synovial fluid sample. In case the investigational device requires revision another biopsy is taken from the synovium and a second sample of the synovial fluid.(At implantation and if applicable at explantation)
- Knee Osteoarthritis and injury Outcome Score (KOOS) Pain(6 weeks, 3 months, 6 months, 12 months and 24 months)
- Europol 5D health utility score(at 6, 12 and 24 months)
- Patient satisfaction on a 5-point Likert scale(at 6 months, 12 months and 24 months)
- Safety - Incidence of secondary surgery of the index knee(6 weeks, 3 months, 6 months, 12 months and 24 months)
- Oxford Knee Score(at 6, 12 and 24 months)
- Knee MRI - Assessment of cartilage condition according to the modified Outerbridge Grading system at screening, 12 and 24 months - Assessment of relative position of the Trammpolin® medial meniscus prosthesis to the tibial plateau(At 12 and 24 months)
研究者
研究点 (3)
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