DRKS00023965暂停不适用
A PMCF-study on bioresorbable mm.IF interference screw for soft tissue fixation at the knee joint - mm.IF study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
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 capable to give informed consent and agreed to participate in the study .
- •(2) Patient is at least 18 years of age at the time of enrollment.
- •(3) Patient requires one of the following primary surgeries: Anterior cruciate ligament (ACL) repair, Medial collateral ligament (MCL) repair, Lateral collateral ligament (LCL) repair, Patellar tendon repair, Posterior oblique ligament (POL) repair, Iliotibial band tenodesis, Medial patellofemoral ligament (MPFL) reconstruction.
- •(4) Patient must be treated with mm.IF bioresorbable interference screw for soft tissue fixation according to the instructions for use.
- •(5) Ability and willingness to adhere to study follow-up.
排除标准
- •1) Patient is pregnant or plans to become pregnant during the study, 2) Patient of a vulnerable group: Patients with incurable diseases; Patients in nursing homes; Patients in emergency situations; Homeless, nomads or refugees; Persons who are accommodated in an institution by court or official order, 3) Patient has conditions that may interfere with graft survival or outcome (e.g., osteoarthritis, severe cartilage damage, Paget disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease), 4) Insufficient bone quantity or quality according to the investigator’s assessment, 5) Inadequate circulation, e.g. peripheral arterial disease, 6) Present tumor or infection disease or previous local infection or increased risk of infection, 7) History of ligament or meniscal surgery or fracture on the affected knee, 8) Known allergy to the study device and or any of its components, 9) In the opinion of the investigator, patient has an emotional or neurological condition that would pre-empt their willingness to participate in the study, including mental illness, drug or alcohol abuse, 10) Patient is entered in another investigational drug or device trial (pre-market), or has been treated with an investigational product in the past 30 days, 11) Patient is known to be at risk for loss to follow-up or failure to return for scheduled study visits, 12) Patient is personally dependent on the investigator or the sponsor of the study
研究者
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