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临床试验/DRKS00023966
DRKS00023966招募中不适用

An MR imaging study on bioresorbable mm.IF interference screw for graft fixation in ACL repair - mm.IF imaging study

Medical Magnesium GmbH0 个研究点目标入组 15 人开始时间: 2022年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • (1) Patient is at least 18 years of age at the time of enrollment.
  • (2) Patient requires surgical reconstruction of the anterior cruciate ligament (ACL).
  • (3) Patient must be treated with mm.IF bioresobable interference screw for soft tissue fixation according to the manufacturers instructions for use
  • (4) Ability and willingness to adhere to study follow-up.
  • (5) Patient is able to give informed consent for study participation.

排除标准

  • (1) Patient is a minor or incapable of giving informed consent
  • (2) Patient is pregnant or plans to become pregnant during the study
  • (3) Patient of a vulnerable group (Patients with incurable diseases, Patients in nursing homes, Patients in emergency situations, Homeless, nomads or refugees, Patients who are accommodated under deprivation of liberty pursuant to an administrative or court order or permit)
  • (4) Contraindications for the use of mm.IF interference screw according to the manufacturer's instructions
  • (5) History of ligament or meniscal injury or fracture of the affected knee
  • (6) Present tumor or infectious disease or previous local infection or increased risk of infection
  • (7) In the opinion of the investigator, patient has an emotional or neurological condition that would pre-empt the willingness to participate in the study, including mental illness, drug, or alcohol abuse
  • (8) Patient is entered in another investigational drug or device study, or has been treated with an investigational product in the past 30 days
  • (9) Patient is known to be at risk for loss to follow-up or failure to return for scheduled study visits
  • (10) Patient is personally dependent on the investigator or the sponsor of the study
  • Additional MR specific contraindications:
  • (11) Patient carries one of the following implants: Cardiac pacemaker, Defibrillator (ICD), Left Ventricular Assistant Device (LVAD), Cochlea implant, Neurostimulator, Insulin or analgesic pump, Coronary artery implant, Corpus cavernosum implant, Bladder pacemaker, MRI incompatible heart valve replacement
  • (12) Metal shards in close proximity to eyes, brain and/or near vessel
  • (13) Metallic trans- or subdermal jewelry implants
  • (14) Large tattoos made of dyes with metallic contents
  • (15) Magnetically fixed denture
  • (16) Vascular stent implanted less than 72 hours ago
  • (17) Metallic joint prosthesis or other metal implants for bone stabilization implanted less than 6 weeks ago
  • (18) Acute myocardial infarction
  • (19)Claustrophobia
  • (20) MRI examinations are burdensome due to age or individual constitution

研究者

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