EUCTR2011-003594-28-DE进行中（未招募）1 期
A Comparative Observational Prospective Randomized Open-Label Study on Efficacy of BioSeed®-C and chondrotissue® Treatment of Local Femoral Cartilage Defects in the Knee. - Comparison of BioSeed®-C treatment with advanced microfracture treatment
BioTissue Technologies GmbH0 个研究点开始时间: 2011年11月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Local femoral defect at the knee joint (Outerbridge class III or IV)
- •Defects at the lateral and medial chondyle
- •Cartilage defect size: (after defect cleaning)
- •Patients male and female between 18 and 50 years of age at the time of surgery
- •Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical evaluations/visits
- •Patients who have signed the Ethics Committee-approved Informed Consent Form prior to surgery
- •Indications for microfracture or ACT respectively
- •focal and contained lesions
- •full-thickness loss of articular cartilage in weight-bearing areas
- •unstable cartilage covering the underlying intact subchondral bone
- •degenerative changes in a knee that is normally aligned
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known allergic reactions or hypersensitivity to bovine proteins, PGA, fibrinogen, thrombin, heparin or hyaluronan
- •Defect of the femoropatellar joint
- •Varus and valgus (more than 5°) (30 cm one leg standing apical X-ray)
- •General osteoarthritis (two or more compartments)
- •Rheumatoid arthritis or Bechterew’s disease
- •Joint stiffness (flexion less than 90°)
- •Obesity > 32 BMI
- •Meniscus lesions with more than 1/3 partial resection
- •History with previous cartilage surgery (osteochondral transplantation (OCT), autologous chondrocyte transplantation (ACT))
- •History with previous microfracture in the symptomatic defect less than 6 months
- •History with previous knee surgery (anterior crucial ligament, meniscus refixation, osteotomy) less than 6 months
- •Osteochondral defects
- •Planned pregnancy, pregnancy and breastfeeding
- •Autoimmune-diseases
研究者
相似试验
招募中
Unknown
sides sealing technique & E-C technique mask holdingCTRI/2023/08/056585Thilakaraj kuppusamy
尚未招募
不适用
A STUDY BETWEEN 2 GROUPS TO DETERMINE THE EFFECT OF CLONIDINE DRUG IN REQUIREMENTS OF INDUCTION AGENT FOR PATIENTS UNDERGOING CABG SURGERY.CTRI/2022/08/044818Rahul Sarkar
招募中
不适用
A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancerprostate cancerJPRN-UMIN000033343Saitama Medical University International Medical Center90
尚未招募
4 期
Effect of Tab.Imeglimin in reducing blood sugar when compared with Tab.Sitagliptin in patients with Type 2 DiabetesCTRI/2024/03/064762Government Kilpauk Medical College
尚未招募
不适用
COMPARITIVE STUDY BETWEEN DEXMEDETOMEDINE AND BUPRENORPHINE AS AN ADJUVANT TO ROPIVACAINE 0.5% IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB ORTHOPEDIC SURGERIESCTRI/2021/10/037274Sanjay Gandhi Institute Of Trauma And Orthopedics