NL-OMON47786已完成不适用
Study Protocol Title: A Prospective, Open-Label, Multicenter Pivotal Study to Evaluate the Safety and Efficacy of GelrinC® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle: A Comparison to Historical Control Microfracture - SAGE
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 64（—）
入选标准
- •1. Patient signed written informed consent.
- •2. Age between 18 and 50.
- •3. Patients must be skeletally mature.
- •4. Single, contained, symptomatic cartilage lesion of the knee predominantly located on the femoral condyle.
- •5. ICRS grade III or IV lesion.
- •6. Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in diameter.
- •7. BMI *35.
- •8. Contralateral knee is asymptomatic, stable, fully functional and not medically treated.
- •9. Agree to actively participate in a strict rehabilitation protocol and follow-up program.
- •10. Agree to use pain medication only according to the following instructions: NSAIDs or combination preparation (of paracetamol/acetaminophen with codeine or similar max 4g/day) must be discontinued 2 weeks prior to baseline and 6, 12, 18, 24, 36, 48 and 60 month visits. Paracetamol/acetaminophen mono preparation (max 4g/day) must be discontinued one week prior to baseline and 6, 12, 18, 24, 36, 48 and 60 month visits.
- •11. Females of childbearing potential are willing to use a proven method to prevent pregnancy during the 24 months post-GelrinC procedure;Intra-operative confirmation:
- •12. Single contained symptomatic lesion located on the femoral condyle of the femur graded as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate.
- •Note: Concurrent Grade I and II defects are allowed on the condyle, patella, tibia or trochlea with the exception of kissing lesions. These asymptomatic lesions
- •should remain untreated (or may be treated with debridement only) at the time of the arthroscopy and/or mini-arthrotomy.
- •13. Defect size between 1 - 5cm2 post debridement and less than or equal to 2.5 cm in diameter.
- •14. Lesion is fully visible and accessible with the GelrinC accessory kit.
排除标准
- •1. Presence of an additional Grade III or IV symptomatic lesion.
- •2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data (this includes but not limited to any chronic debilitating systemic disease, any other unstable cardiac or pulmonary disorders).
- •3. The target lesion is a patellofemoral cartilage lesion.
- •4. Target lesion in the femoral condyle is positioned posteriorly to the posterior horn of the meniscus and cannot be accessed by the GelrinC accessory kit.
- •5. Recent Osteochondritis Dissecans (OD) within 1 year of baseline visit.
- •6. Subchondral sclerosis.
- •7. Advanced osteoarthritis (Radiographic Atlas of OA grade 2-3).
- •8. Untreated ACL and/or PCL deficiency or complex ligamentous instability of the knee.
- •9. Meniscal transplant (previous/present).
- •10. Previous ipsilateral meniscal arrows or sutures (if not resorbed).
- •11. Current untreated meniscal tear.
- •12. A previous meniscal resection was:
- •Within the last 6 months, OR
- •Resulted in remnant that is less than 5mm at the narrowest region, OR
- •Resulted in nonfunctional root attachments.
- •13. Previous tendon repair or ligament reconstruction within the last 6 months.
- •14. Clinically relevant compartment misalignment exceeding 5° (according to x-ray).
- •15. Kissing lesions (symptomatic and asymptomatic).
- •16. Failed Mosaicplasty or ACI or MACI or any other cartilage repair product
- •17. Microfracture performed less than 1 year before baseline visit.
- •Note: prior diagnostic arthroscopy with debridement and lavage is acceptable.
- •18. Received Hyaluronic acid intra-articular injections into the afflicted knee within three months of baseline visit.
- •19. Received Corticosteroids intra-articular injections into the afflicted knee within the last three months of baseline.
- •20. Taking specific OA drugs, such as chondroitin sulfate, diacerein, nglucosamine, piascledine, or capsaicin within two weeks of the baseline visit.
- •21. Taking intramuscular or oral corticosteroids within two weeks of the baseline visit (inhalation corticosteroids are allowed).
- •22. Chronic use of anticoagulants or patients who have any coagulation disorder
- •Note: patients receiving low dose aspirin, temporary anti-platelet therapy or other anticoagulant medication should discontinue these medications per standard surgical procedure practice).
- •23. Known sensitivity to acrylic agents (or any of the components of GelrinC).
- •24. Participation in concurrent or previous clinical trial within three months of the baseline visit.
- •Note: participation in observational clinical trials is allowed.
- •25. Pregnant or breastfeeding.
- •26. Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C, syphilis or any other immune deficiency disease.
- •27. Malignancies:
- •- Current or prior malignancy of the affected limb.
- •- Current or prior malignancies in the body other than the affected limb within the last 5 years.
- •28. Alcohol or drug (including medication) abuse.
- •29. Subjects with documented uncontrolled diabetes (i.e. symptomatic, hyperglycemia that cannot be medically managed, fasting blood glucose level above 300mg/dL, and/or frequent swings between hyperglycemia or hypoglycemia).
- •30. Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted
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