NCT01712191已完成不适用
Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
Phoenix Kinetics14 个研究点 分布在 6 个国家目标入组 128 人开始时间: 2011年1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
- 128
- 试验地点
- 14
- 主要终点
- Knee injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
- •Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
- •Be in neutral alignment +/- 5 degrees of the mechanical axis.
- •Be between age 35 and 75 at the time of the planned surgery.
- •Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
- •Have a normal mental status.
- •Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule.
- •Be able and willing to understand and sign the informed consent form.
排除标准
- •Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
- •Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
- •Have a varus or valgus knee deformity > 5 degrees.
- •Have a laxity level of more than II (ICRS), secondary to previous 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).
- •Have patella instability or non-anatomically positioned patella
- •Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB).
- •Need a tibial osteotomy at the time of surgery.
- •Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device
- •Have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic.
- •Have a knee flexion contracture > 10 degrees
- •Be unable to flex the knee to 90 degrees
- •Have a leg length discrepancy causing a noticeable limp.
- •Have had a previous major knee condyle surgery
- •Present with insufficiency fractures or avascular necrosis of the medial compartment.
- •Have an active infection or tumor.
- •Have any type of knee joint inflammatory disease including Sjogren's syndrome.
- •Have neuropathic knee osteoarthropathy, also known as Charcot joint.
- •Have any medical condition that does not allow arthroscopy at the point of entry to the knee.
- •Be pregnant or is a female intending to become pregnant during the study period.
- •Be mentally incapacitated.
- •Be a prisoner.
- •Be a patient who has economic incentive not to improve (e.g., workman's compensation patient)
- •Be morbidly Obese (BMI > 35).
- •Is unwilling or unable to have an X-ray, Fluro, or MRI of the affected knee
研究组 & 干预措施
NUsurface Meniscus Implant
Experimental
干预措施: NUsurface Meniscus Implant (Device)
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 24 Months
次要结局
未报告次要终点
研究者
研究点 (14)
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