JPRN-jRCT2062220056进行中(未招募)1 期
Clinical Trial for Efficacy and Safety of ARtificial Protein (Silk-elastin, P47K-WAS-MR) in Patients with Meniscus Repair - CARP-SE trial
Adachi Nobuo0 个研究点目标入组 8 人开始时间: 2022年9月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 8
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
- >= 8age old 至 < 60age old(—)
- 性别
- All
入选标准
- •Patients who meet all of the following selection criteria will be considered
- •1) Patients who are at least 8 years old and less than 60 years old at the time of obtaining consent
- •2) Patients whose written consent has been obtained from the patient.
- •If the patient is between 8 and 18 years old, written consent must be obtained from both the patient and a surrogate (parents (or person who has parental authority over the subject), guardian, or other equivalent person).
- •3) Patients diagnosed on MRI images as having a meniscus injury that includes a no-bleeding field (2/3 of the area from the medial margin of the meniscus), either alone or in conjunction with an anterior cruciate ligament injury.
- •4) Patients with limited knee range of motion due to mechanical symptoms (Catching), or fitting symptoms (Locking) resulting from meniscus injury
- •5) Patients whose pain does not improve despite conservative treatment with exercise therapy or analgesics
排除标准
- •Patients who meet any of the following criteria will be excluded from the study
- •1) Patients with a BMI greater than 50 kg/m 2
- •2) Patient underwent total meniscectomy on the affected side
- •3) Patients within 1 year of ligament reconstruction or osteotomy to the affected knee
- •4) Patients who have received an intra-articular injection into the target knee within 2 months prior to obtaining consent
- •5) Diagnosed with osteoarthritis of the knee Patient
- •6) Patients with a knee deformity of more than 10 degree of internal or external rotation relative to normal (FTA 175 degree)
- •7) Patients with a history of autoimmune arthritis (rheumatoid arthritis, etc.), sepsis, gout, pseudogout, pyogenic arthritis, or secondary arthropathy
- •8) Patients diagnosed with diabetes mellitus and poor glycemic control (HbA1c > 7.8 or on insulin therapy)
- •9) Patients with serious illnesses (metastatic cancer of any type, autoimmune diseases, etc.) for which the chance of survival may be less than 2 years
- •10) Patients with a history of allergy to silk, anesthetics, or antiseptics used in this study
- •11) Patients who test positive for at least one of HBs antigen, HCV antibody, or HIV antigen/antibody
- •12) Patients taking the following prescription medications:.
- •Regular use of opioid analgesics, anticoagulants, corticosteroids, growth hormone, testosterone
- •13) Patients on pacemakers, neurostimulators, metal particles, stents, and clips used for implants
- •14) Pregnant or lactating women, and patients who are unable to consent to the use of an effective contraceptive method under medical supervision for up to 12 weeks (Visit 6)
- •15) Patients participating in another clinical trial or other clinical research/study within 6 months of last use of investigational drug or device
- •16) Other patients deemed inappropriate by the investigator/associate investigator
研究者
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