EUCTR2011-005798-22-FR进行中（未招募）1 期
A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 261
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
入选标准
- •Patient is =18 and =65 years old at time of screening.
- •Patient has a localized articular cartilage defect of the femoral condyle or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is =6 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with NOVOCART® 3D plus or microfracture.
- •Patient has a defect size =2 and =6 cm2 post-debridement.
- •Patient has an intact (=Grade 2 International Cartilage Repair Society [ICRS] classification) articulating joint surface (no kissing lesions”).
- •Patient has an intact meniscus (maximum 1/2-resection).
- •Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair has to be done within 6 weeks to the planned cartilage treatment (ACT/microfracture).
- •Patient has free range of motion of the affected knee joint or =10° of extension and flexion loss.
- •Patient has a defect of grade III or IV according to the ICRS classification.
- •Patient has a maximum baseline score of 60/100 on the 2000 International Knee Documentation Committee (IKDC) subjective knee evaluation.
- •Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments and postoperative rehabilitation regimen.
- •Patient benefits of a health insurance regimen
- •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 235
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Only selected (preoperative) exclusion criteria have been listed below. For the complete list see protocol.
- •Preoperative exclusion criteria:
- •Patient is unable to undergo magnetic resonance imaging (MRI).
- •Patient has prior surgical treatment of the target knee using mosaicplasty and/or microfracture. (Note: prior diagnostic arthroscopies with debridement and lavage are acceptable). Anterior cruciate ligament repair are accepted, if the target knee is stable or a primary ACL reconstruction is performed within 6 weeks to the planned cartilage treatment (ACT/microfracture).
- •Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade =2.
- •Patient has chronic inflammatory arthritis and/or infectious arthritis.
- •Patient has joint space narrowing >1/3 in the target knee when compared to the other knee or <3 mm joint space measured on X-ray.
- •Patient has an instable knee joint or unsufficiently reconstructed ligaments. If ligament repair is necessary, the repair has to be performed within 6 weeks to the planned cartilage treatment (ACT/microfracture).
- •Patient has malalignment (no valgus- or varus-deformity) in the target knee. In suspected cases, the mechanical axis must be established radiographically through complete leg imaging during standing and in a.p. or rather p.a. projection. The Mikulicz line is not allowed to deviate more than 5 mm of the Eminentia intercondylaris. If alignment is necessary, surgery has to be performed within 6 weeks to the planned cartilage treatment (ACT/microfracture).
- •Patient has an osteochondral defect.
- •Patient has bilateral lower limb pain or low back pain.
- •Patient has a known systemic connective tissue disease.
- •The patient has a known history of HIV/AIDS.
- •The patient has a known history of Treponema pallidum (syphilis).
- •The patient has an active hepatitis B or C infection with verified antigens. Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
- •The patient has at the site of surgery an active systemic or local microbial infection, eczematization or inflammable skin alterations.
- •Patient has a known history of cancer.
- •Patient is taking indomethacin or other NSAIDS as acute anti-pain and/or anti-inflmmatory medication.
- •Patient has a known history of osteoporosis; also patients with primary hyperparathyroidism, hyperthyroidism, chronic renal failure or patients with prior pathological fractures independent of the genesis.
- •Patient has a body mass index (BMI) >35 kg/m2.
- •Intra-operative exclusion criteria:
- •Patients may be excluded intraoperatively during the surgical procedure prior to randomization. None of the following exclusion criteria can apply to any enrolled patient:
- •Patient has a defect size <2 or >6cm² post-debridement.
- •Patient has >2 independent cartilage lesions of a total defect size of >6cm² that are not located at the femoral condyle and/or the trochlea in the knee to be treated with NOVOCART® 3D plus or microfracture.
- •Patient is indicated for concurrent meniscu
研究者
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