NL-OMON41631已完成不适用
Treatment of the Medial Meniscus with the NUsurface® Meniscus Implant. A Prospective, Multi-Center, Open Label, Non-randomized Study of the NUsurface® Meniscus Implant - NUsurface Meniscus Implant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be included in the NUsurface study the patient must have medial compartment knee pain and ALL of the following conditions:
- •1.Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
- •2.Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
- •3.Be in neutral alignment +/- 5 degrees of the mechanical axis.
- •4.Be between age 35 and 75 at the time of the planned surgery.
- •5.Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
- •6.Have a normal mental status.
- •7.Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule.
- •8.Be able and willing to understand and sign the informed consent form.
排除标准
- •The patient is excluded from the study if ANY of the following conditions are met for the involved knee:
- •1.Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
- •2.Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
- •3.Have a varus or valgus knee deformity > 5 degrees.
- •4.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).
- •5.Have patella instability or non-anatomically positioned patella
- •6.Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB).
- •7.Need a tibial osteotomy at the time of surgery.
- •8.Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device
- •9.Have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic.
- •10.Have a knee flexion contracture > 10 degrees
- •11.Be unable to flex the knee to 90 degrees
- •12.Have a leg length discrepancy causing a noticeable limp.
- •13.Have had a previous major knee condyle surgery
- •14.Present with insufficiency fractures or avascular necrosis of the medial compartment.
- •15.Have an active infection or tumor.
- •16.Have any type of knee joint inflammatory disease including Sjogren*s syndrome.
- •17.Have neuropathic knee osteoarthropathy, also known as Charcot joint.
- •18.Have any medical condition that does not allow arthroscopy at the point of entry to the knee.
- •19.Be pregnant or is a female intending to become pregnant during the study period.
- •20.Be mentally incapacitated.
- •21.Be a prisoner.
- •22.Be a patient who has economic incentive not to improve (e.g., workman*s compensation patient)
- •23.Be morbidly Obese (BMI > 35).
- •24.Is unwilling or unable to have an X-ray, Fluro, or MRI of the affected knee
研究者
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