NCT02483988已完成不适用
The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant). A Multi-center, Single-arm, Prospective, Open-label, Non-randomized, Observational Clinical Study
Phoenix Kinetics26 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2015年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 26
- 主要终点
- Safety assessed by Serious and non-serious, device-related and non-device related adverse events
研究概览
简要总结
The NUsurface® Meniscus Implant SUN Clinical Trial is a multi-center, single-arm, prospective, open label, non-randomized, observational clinical trial to gather safety and probable clinical benefit data on the NUsurface® Meniscus Implant in treated the target population.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
- •Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)
- •Is between age 30 and 75 years (inclusive) at the time of study treatment
- •Has neutral alignment ±5º of the mechanical axis, as measured from 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 and the center of the ankle joint
- •Has ≥ 2 mm intact medial meniscal rim capable of being fitted with a NUsurface® device
- •Is able to do the study required follow-up visits, questionnaires, X-rays and MRI's
- •Is able to read and understand the English language if treated at a U.S. site or read and understand one of the official country languages if treated at a site Outside the U.S.
- •Is able and willing to understand and sign the Informed Consent Form
排除标准
- •Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy leaving > 4 mm of medial meniscus rim
- •Has evidence of a Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a NUsurface implant (e.g., a focal lesion > 0.5 cm2 correlating to a circular defect of > 8 mm in diameter)
- •Has complete disruption of the posterior root attachment of the meniscus
- •Has lateral compartment pain and Grade III or Grade IV Outerbridge cartilage score in the lateral compartment
- •Has a varus or valgus knee deformity > 5º requiring a tibial or femoral osteotomy
- •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 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 study treatment
- •Has a BMI > 32.5 at the start of study treatment
- •Decides to receive (if eligible and an option) allograft medial meniscus transplantation
- •Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the NUsurface® Meniscus Implant
- •Has a knee flexion contracture > 10º
- •Has flexion < 90º
- •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 hyaluronic acid injections (i.e., patients with known hypersensitivity [allergy] to hyaluronan [sodium hyaluoronate] preparations); patients having knee joint infections or skin diseases or infections in the site of possible injections
- •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 study treatment
- •Has chondrocalcinosis
- •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
- •Is a patient who has economic incentive not to improve
- •Certain patient populations that are at high risk for poor healing or outcomes such as patients who have a co-morbidity that reduces life expectancy to less than 36 months
- •Patients who are contraindicated for MRI (i.e., pacemaker, defibrillator, cochlear implants, etc.)
研究组 & 干预措施
NUsurface Meniscus Implant
Experimental
All eligible patients will receive the NUsurface® Meniscus Implant.
干预措施: NUsurface® Meniscus Implant (Device)
结局指标
主要结局
Safety assessed by Serious and non-serious, device-related and non-device related adverse events
时间窗: 2 years
Safety assessed by Serious and non-serious, device-related and non-device related adverse events recorded during the implantation, up to 24 months following implantation
Clinical Performance
时间窗: 2 years
Evaluation of performance defined as NUsurface® Meniscus Implant providing knee pain reduction and improvement in functionality and quality of life up to 24 months post-implantation, as measured by KOOS Pain and KOOS 5
次要结局
- Safety assessed by Serious and non-serious, device-related and non-device related adverse events(5 years)
- Clinical Performance(5 years)
研究者
研究点 (26)
Loading locations...
相似试验
已完成
不适用
The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System)MeniscectomyOsteoarthritisNCT02136901Active Implants34
已完成
不适用
Verifying the Effectiveness of the NUsurface® SystemMeniscectomyOsteoarthritisNCT02108496Active Implants337
已完成
不适用
Treatment of the Medial Meniscus With the NUsurface(R) Meniscus ImplantDegeneration MeniscusOsteoarthritis, KneeNCT01712191Phoenix Kinetics128
已完成
不适用
Clinical Trial of the Senza™ SCS System in the Treatment of Chronic Upper Limb and Neck PainNeck PainChronic PainNCT02385201Nevro Corp100
已完成
不适用
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)Urinary IncontinenceUrge IncontinenceNocturiaUrinary Frequency More Than Once at NightBowel Disorders FunctionalUrinary Incontinence, UrgeIncontinence, Nighttime UrinaryFecal IncontinenceNCT05368246InnoCon Medical80