跳至主要内容
临床试验/JPRN-jRCT2062220056
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

发起方
Adachi Nobuo

相似试验

Clinical Trial for Efficacy and Safety of ARtificial... | 临床试验