NL-OMON46495已完成不适用
Treatment of medial knee joint pain with the Trammpolin® meniscus prosthesis. - AIR - study
ATRO Medical B.V.0 个研究点目标入组 12 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
- 12
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. 1. Has medial compartment joint pain with > 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 0 is no pain)
- •3. Is between age 30 and 65 years (inclusive) at the time of screening
- •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, as confirmed by X-ray
- •5. Is willing to be implanted with the Trammpolin® meniscus prosthesis.
- •6. Is able to do the study required follow up visits, questionnaires, X-rays, CT-scans, and MRI*s
- •7. Is able and willing to understand and sign the study 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 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 Trammpolin® meniscus prosthesis (e.g., a focal lesion > 0.5 cm correlating to a circular defect of > 8 mm in diameter)
- •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 > 5º requiring a tibial or femoral osteotomy
- •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 > 32.5 at the time of screening
- •12. Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the Trammpolin® meniscus prosthesis
- •13. Has a knee flexion contracture > 10º
- •14. Has flexion < 90º
- •15. Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)
- •16. Has insufficiency fractures or avascular necrosis of the medial compartment
- •17. Has an active infection or tumor (local or systemic)
- •18. Has any type of knee joint inflammatory disease including Sjogren*s syndrome
- •19. Has neuropathic knee osteoarthropathy, also known as Charcot joint
- •20. Has any medical condition that does not allow possible arthroscopy of the knee
- •21. Has neurological deficit (sensory, motor, or reflex)
- •22. Is currently involved in another investigation of the lower extremity
- •23. Anticipates having another lower extremity surgery during the study period
- •24. Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
- •25. Has received any corticosteroid knee injections * 3 months prior to surgery
- •26. Has chondrocalcinosis
- •27. Has proven osteoporosis
- •28. Is on immunostimulating or immunosuppressing agents
- •29. 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)
- •30. Is a female who is lactating, expecting, or is intending to become pregnant during the study period
- •31. Is an active smoker
- •32. Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer*s)
- •33. Is a prisoner
- •34. Has a condition or be in a situation that, in the Investigator*s opinion, may confound the study results, or may interfere significantly with the subject*s participation in the study.
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