The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-centered, Prospective, Randomized, Interventional, Superiority Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 337
- 试验地点
- 15
- 主要终点
- NUsurface Device Related Complications
研究概览
简要总结
The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for performing this clinical study is to gather clinical data to evaluate the safety and effectiveness of the NUsurface device compared to the Standard of Care.
详细描述
The NUsurface® Meniscus Implant is intended for use in patients with medial compartment pain that have had a previous partial medial meniscectomy.
Patients who meet the inclusion/exclusion criteria will be assigned by balanced randomization into one of two groups: the Meniscus Implants versus non-surgical standard of care. The KOOS (Knee injury and Osteoarthritis Outcome Score) and IKDC (International Knee Documentation Committee) forms will be used to provide a comprehensive evaluation of the patients' pre-intervention and post-intervention condition including activity levels, pain, swelling, locking, stability, support, sports activity, and quality of life assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •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 AND is also recommended for the baseline non-surgical (and, if likely to receive benefit, any injection) therapies to be administered in the study.
- •Is willing to be entered into either arm of the study: implanted with the NUsurface device OR treated with the recommended control arm therapies.
- •Is willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule
- •Is able and willing to understand and sign the Informed Consent Form
- •Is able to read and understand the English language
- •Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)
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 time 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 hyaluronate] 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
结局指标
主要结局
NUsurface Device Related Complications
时间窗: 2 years
The device related complications of the NUsurface Meniscus Implant during the 24-month post-operative period in regard to secondary surgical intervention of the NUsurface device.
KOOS Scale
时间窗: 2 years
The KOOS Pain Subscale and KOOS Overall Scale (Average of the 5 KOOS Subscales) relative to baseline - all at 24 months.
Overall Success Composite Endpoint
时间窗: 2 years
Overall Success is a composite endpoint computed at 24-Months whereby a subject must satisfy the pre-defined KOOS goals (KOOS Success), must have completed 24 Months with no disqualifying surgical intervention, and must have completed 24 Months with no device fracture and no subluxation on MRI confirmation.
Automatic Study Failure
时间窗: 2 Years
The automatic treatment failure of the Control Group during the first 24-month period is any surgical intervention of the index knee. The automatic treatment failure of the Investigational Group during the first 24-month period is device removal or MRI detection of a dislocation or device fracture.
KOOS Success
时间窗: 2 years
KOOS Success is an element that contributes to Overall Success by computing KOOS Pain Subscale at 24 months compared to baseline, and KOOS Overall score at 24 months compared to baseline. Scores for each of the five subscales are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. For a subject to have KOOS Success their KOOS measures must be: KOOSpain ≥ 86.1 at 24 Months AND KOOSoverall ≥ 86.2 at 24 Months. Alternatively, a subject can have KOOS Success if KOOSpain ∆ (improvement from Baseline) ≥ 20 points at 24 Months AND KOOSoverall ∆ ≥ 20 points at 24 Months AND KOOSpain ≥ 40 points at 24 Months.
次要结局
- KOOS Subscale - Pain(2 Years)
- KOOS Subscale - Symptoms(2 Years)
- KOOS Subscale - ADL(2 Years)
- KOOS Subscale - Sports and Recreation(2 Years)
- KOOS Subscale - Quality of Life(2 Years)
- KOOS Overall Score(2 Years)
- VAS Pain Score(2 Years)
- WOMET Normalized Score(2 Years)
- IKDC Subjective Knee Score(2 Years)