NL-OMON54484已完成不适用
Feasibility of the Artimis*medial meniscus prosthesis intended to restore the medial meniscus function to provide pain relief after meniscectomy - AIR (Artificial Implant to Restore the medial meniscus function)2
ATRO Medical B.V.0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- •1. Has medial compartment knee pain and had a medial partial or total
- •meniscectomy > 6 months ago. The lack of meniscus tissue is confirmed by
- •patient history and MRI
- •2. Has a KOOS Pain of <= 75 (100 being no pain and the highest attainable score)
- •3. Is between age 18 and 70 years (inclusive) at the time of screening
- •4. Has neutral alignment ± 5° 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, as
- •confirmed by X-ray
- •5. Is willing to be implanted with the Artimis* meniscus prosthesis
- •6. Is willing and able to comply to the clinical investigation required follow
- •up visits, questionnaires, X-rays and MRI*s
- •7. Is able and willing to understand and sign the clinical investigation
- •Informed Consent Form
- •8. Is able to read and understand the national language of the country in which
- •the relevant clinical site is located
排除标准
- •1. Has a symptomatic knee because of a tear that could potentially be addressed
- •by a repeat partial meniscectomy
- •2. Has evidence of a modified Outerbridge Grade IV cartilage loss on the medial
- •tibial plateau or femoral condyle that potentially could contact a Artimis*
- •medial meniscus prosthesis
- •3. Has lateral compartment pain and Grade III or Grade IV modified Outerbridge
- •cartilage score in the lateral compartment
- •4. Has a varus or valgus knee deformity of > 5° requiring a tibial or femoral
- •5. Has a varus alignment that is not passively correctable
- •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 modified 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 surgery
- •11. Has a BMI > 30 at the time of screening
- •12. Has a knee flexion contracture > 10°
- •13. Has a knee flexion < 90°
- •14. Had a previous High Tibial Osteotomy (HTO) < 1 year ago
- •15. Has insufficiency fractures or avascular necrosis of the medial compartment
- •16. Has an active infection or tumor (local or systemic)
- •17. Has any type of knee joint inflammatory disease including Sjogren*s syndrome
- •18. Has neuropathic knee osteoarthropathy, also known as Charcot joint
- •19. Has any medical condition that does not allow possible arthroscopy of the
- •20. Has neurological deficit (sensory, motor, or reflex)
- •21. Is currently involved in another investigation of the lower extremity
- •22. Anticipates having another lower extremity surgery during the clinical
- •investigation period
- •23. Has received any corticosteroid knee injections <= 3 months prior to surgery
- •24. Has proven osteoporosis
- •25. Is on immunostimulating or immunosuppressing agents
- •26. 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)
- •27. Is a female who is lactating, expecting, or is intending to become pregnant
- •during the clinical investigation period
- •28. Is mentally incapacitated (incapable of appraising or controlling conduct)
- •or have mental disability (e.g., dementia or Alzheimer*s)
- •30. Has a condition or be in a situation that, in the Investigator*s opinion,
- •may confound the clinical investigation results, may risk the safety of the
- •patient, or may interfere significantly with the subject*s participation in the
- •clinical investigation
研究者
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