NL-OMON40108已完成不适用
Single arm, Open Label, Multi-Centre study to evaluate the safety and performance of treatment of articular cartilage lesions located on the femoral condyle with GelrinC - GelrinC CLN-004-00
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
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. Males or females >= 18 and <= 65 years of age.
- •2. One or two symptomatic lesions to the femoral condyle; patient must present with pain in the index knee of moderate or severe level (VAS score >=5)
- •3. If Female: Actively practicing a contraception method, or practicing abstinence, or surgically sterilized, or postmenopausal
- •4. Understands and voluntarily signs and dates an informed consent document.
- •5. At least one lesion with Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion
- •6. Willingness to follow standardized rehabilitation procedures.
- •7. Willingness and ability to comply with the requirements of this protocol, including returning for evaluation (clinical and imaging) at periodic intervals post-treatment.
- •8. Study knee has intact ligaments
- •9. Ipsilateral knee compartment has intact menisci (or requires partial menistectomy resulting in stable menisci)
- •10. Contralateral knee is asymptomatic, stable and fully functional.
- •11. MRI obtained preoperatively within 3 months of Surgery.;Intra-operative arthroscopic confirmation:
- •1. One or two symptomatic lesions located on the femoral condyle of the femur rated each as ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate
- •2. Individual defect size between 1 cm2 - 6 cm2 after arthroscopic debridement.
排除标准
- •1. More than two Grade III or IVA symptomatic lesions (more asymptomatic lesions are allowed)
- •2. Untreatable Posterior symptomatic lesion
- •3. Lesion greater than 6cm2
- •4. ICRS Grade larger than grade II on a surface that directly opposes the defect
- •5. Diffuse Osteoarthritis or avascular necrosis (clinical and/or radiographic diagnosis)
- •6. History of autoimmune disease or inflammatory arthropathy
- •7. History of chronic debilitating systemic disease and any other unstable cardiac and pulmonary disorders.
- •8. History of current or prior malignancy within the last 5 years.
- •9. Patients treated in the affected knee with microfracture in the last 12 months or had tendon repair, meniscus repair, ligament repair or realignment surgery in the affected knee within the last 6 months.
- •10. Patient with prior total or subtotal meniscectomy.
- •11. Body Mass Index (BMI) >32 Kg/m2
- •12. `Patients with known HIV, Hepatitis A, B, or C infections or other immunedeficient state.
- •13. Patients requiring immuno-suppressive medications.
- •14. Clinically significant organic disease
- •15. Patients received any other investigational products within 6 months prior to study enrollment.
- •17. Taking specific OA drugs within 2 weeks of the screening
- •18. Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulant, or taking corticosteroids
- •19. Uncontrolled diabetes
- •20. Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee
- •21. Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- •22. Any evidence of the following diseases in the target joint :septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone,ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation
- •23. Current diagnosis of osteomyelitis
- •24. Liver enzymes (SGOT, SGPT, Alkaline Phosphatase) of more than two times the upper limit of normal or any other result that is clinically important according to the Investigator
- •25. CRP > 10 mg/l
- •26. Clinically significant abnormal finding on screening laboratory parameters.
- •27. Clinically relevant compartment mal-alignment (> 5 degrees)
- •28. Patients with a history of bleeding disorders, patients receiving anti-platelet therapy or other anticoagulant medication use within 10 days prior to the beginning of the study, or patients in whom antiplatelet or other anticoagulant medication use is anticipated during the course of the study.
- •29. Symptomatic lesion to the trochlea
- •30. Any condition that prevents the patient from undergoing MRI evaluation
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