EUCTR2009-016466-82-DE进行中（未招募）1 期
Prospective, randomised, open label, multicentre Phase-III clinical trial to compare the efficacy and safety of the treatment with the autologous chondrocyte transplantation product co.don chondrosphere® (ACT3D-CS) with microfracture in subjects with cartilage defects of the knee with a defect size between 1 and 4 cm2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CO.DON AG
- 入组人数
- 102
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
- 性别
- All
入选标准
- •1. Male or female patients, age: between 18 and 50 years
- •2. Defect: isolated ICRS grade III or IV single defect chondral lesion on femoral condyle
- •3. Defect size: 1 to < 4 cm2 after debridement to healthy cartilage up to 6 mm in depth. Assessment with MRI at screening and per estimation during arthroscopy prior to randomization
- •4. Nearly intact chondral structure surrounding the defect as well as an intact corresponding joint area
- •5. Informed consent signed and dated by patient
- •6. Patient understands the strict rehabilitation protocol and follow-up programme and is willing to follow it
- •7. In case of pain, patient agrees to use only paracetamol mono- (max 4 g/day) or combination preparation and oral and/or topic NSAIDs during the trial and to discontinue the use of oral and/or topic NSAIDs and/or paracetamol combination preparation 1 week before each visit whereas the use of paracetamol mono-preparation (max 4 g/day) is allowed. However, in the morning of the visit day, no pain medication is allowed. Other pain medications are allowed during surgical procedure and may be taken for a period not exceeding 4 weeks after surgery.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 102
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Defects on both knees at the same time
- •2. Radiological signs of osteoarthritis
- •3. Osteochondritis dissecans (OCD)
- •4. Any signs of knee instability
- •5. Valgus or varus malalignment (more than 5° over the mechanical axis)
- •6. Clinically relevant second cartilage lesion on the same knee
- •7. More than 50 % resection of a meniscus in the affected knee or incomplete meniscal rim
- •8. Rheumatoid arthritis, parainfectious or infectious arthritis, and condition after these diseases
- •9. Pregnancy and planned pregnancy (no MRI possible)
- •10. Obesity (Body Mass Index >30)
- •11. Uncontrolled diabetes mellitus
- •12. Serious illness
- •13. Poor general health as judged by physician
- •14. Participation in concurrent clinical trials or previous trials within 3 months of screening
- •15. Previous treatment with ACT in the affected knee
- •16. Microfracture performed less than 1 year before screening in the affected knee
- •17. Alcohol or drug (medication) abuse
- •18. Meniscal transplant in the affected knee
- •19. Meniscal suture (in the affected knee) three months prior to baseline
- •20. Mosaicplasty (Osteoarticular Transplant System, OATS) in the affected knee
- •21. Having received hyaluronic acid intra-articular injections in the affected knee within the last 3 months before baseline
- •22. Taking specific ostheoarthritis drugs such as chondroïtin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks before baseline
- •23. Corticosteroid treatment by intraarticular route within the last month of baseline or systemic (all routes) corticosteroids within the last 2 weeks before baseline
- •24. Chronic use of anticoagulants
- •25. Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee
- •26. Any clinically significant or symptomatic vascular or neurological disorder of the lower extremities
- •27. Any evidence of the following diseases in the affected knee: septic arthritis, inflammatory joint disease, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, haemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation
- •28. Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C virus (HCV) infection
研究者
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