NL-OMON46974已完成不适用
The VENUS (Verifying the Effectiveness of the NUsurface® System) Clinical Study - VENUS study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria: In the opinion of the investigator, if ALL of the following 8 conditions are applicable for the index knee, then the patient is included if he/she: ;1. Had > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
- •2. Has a KOOS Pain of * 75 (100 being the highest attainable and no pain)
- •3. Is between age 30 and 75 years (inclusive) at the time of study treatment
- •4. Has neutral alignment ± 5º 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
- •5. 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.
- •6. Is willing to be entered into either arm of the study: implanted with the NUsurface device OR
- •treated with the recommended control arm therapies.
- •7. Is able to do the study required follow up visits, questionnaires, X-rays, and MRI*s
- •8. Is able and willing to understand and sign the study Informed Consent Form
- •9. Is able to read and understand the national language of the country in which the relevant clinical site is located
排除标准
- •Exclusion Criteria: If ANY of the following 35 conditions are applicable, then the patient is excluded if he/she:;1) Has a symptomatic knee because of a tear that could be addressed by a repeat partial
- •meniscectomy leaving > 4 mm of medial meniscus rim
- •2) 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 cm correlating to a circular defect of > 8 mm in diameter)
- •3) Has complete disruption of the posterior root attachment of the meniscus
- •4) Has lateral compartment pain and Grade III or Grade IV Outerbridge cartilage score in the lateral
- •compartment
- •5) Has a varus or valgus knee deformity > 5º requiring a tibial or femoral osteotomy
- •6) 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)
- •7) Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment
- •8) Has patellar compartment pain and Grade III or Grade IV Outerbridge cartilage score in the
- •patellar compartment.
- •9) 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
- •10) Had an ACL reconstruction performed < 9 months prior to study treatment
- •11) Has a BMI > 32.5 at the time of study treatment
- •12) Decides to receive (if eligible and an option) allograft medial meniscus transplantation
- •13) Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or
- •ceramic, not including the NUsurface® Meniscus Implant
- •14) Has a knee flexion contracture > 10º
- •15) Has flexion < 90º
- •16) Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial
- •Osteotomy (HTO)
- •17) Has insufficiency fractures or avascular necrosis of the medial compartment
- •18) Has an active infection or tumor (local or systemic)
- •19) Has any type of knee joint inflammatory disease including Sjogren*s syndrome
- •20) Has neuropathic knee osteoarthropathy, also known as Charcot joint
- •21) Has any medical condition that does not allow possible arthroscopy of the knee
- •22) Has neurological deficit (sensory, motor, or reflex)
- •23) Is currently involved in another investigation of the lower extremity
- •24) Anticipates having another lower extremity surgery during the study period
- •25) 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
- •26) Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
- •27) Has received any corticosteroid knee injections * 3 months prior to study treatment
- •28) Has chondrocalcinosis
- •29) Is on immunostimulating or immunosuppressing agents
- •30) 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)
- •31) Is a female who is
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