KCT0009031招募中Unknown
A prospective, multi-center, single blind, randomization, clinical trial to evaluate the efficacy and safety of partial meniscal transplantation using BIOMENISCUS GRAFT and partial meniscectomy in Meniscal Injury patients
Cellumed0 个研究点目标入组 72 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 72
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
- 16(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •1. Patients who need 20% or more resection of medial or lateral cartilage
- •2. Patients who maintain the tension of the marginal edge of the meniscus
- •3. Acute and chronic patients (including 1 cartilage discectomy or suture)
- •4. Patients aged 16-60
- •5. Patients with more than 1 mm cartilage plate rim and anterior and olfactory angles
- •6. Patients with normal lower limb alignment
- •7. Patients with no ligament damage to the affected knee joint (including those without ligament instability among patients 2 years after ligament surgery)
- •8. If the cartilage lesion is not severe
排除标准
- •1. Patients with all cartilage plates removed
- •2. Patients with subtotal cartilage resection and loss of rim of the cartilage plate over 1 mm and continuity of the anterior and olfactory angles.
- •3. In case of severe cartilage lesion (Outerbridge Grade IV)
- •4. Patients with ligament instability in the knee area to be operated on
- •5. Patients with rheumatoid arthritis, inflammatory or purulent arthritis, and autoimmune diseases
- •6. Patients with evidence of osteonecrosis in the knee to be operated on
- •7. Kellgren-Lawrence grade IV arthritis patient
- •8. Patients with uncorrected deformity or abnormal lower limb alignment in the knee to be operated on
- •9. Patients with a history of anaphylaxis due to immune rejection of the implant
- •10. Patients systemically administered adrenocorticosteroids, anti-tumor drugs, immunostimulants or immunosuppressants within 30 days of surgery
- •11. Patients with systemic or local infectious diseases
- •12. Pregnant women, nursing women, or those who disagree with contraception* during this clinical trial
- •*Contraception: oral contraceptives (limited to those who have been continuously taking at least 3 months before application of clinical trial medical devices), hormonal contraceptives, implantation of intrauterine devices or intrauterine systems, double blocking method (male: spermicide and condom , Female: vaginal diaphragm for contraception, vaginal sponge or neck cap), sterilization procedure (vasectomy, tubal ligation, etc.)
- •13. Patients with neurological disorders unable to participate in rehabilitation programs after surgery
- •14. Patients with allergies to collagen of animal origin
- •15. Patients allergic to sodium chondroitin sulfate, an animal-derived substance
研究者
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