JPRN-jRCTs031220100招募中2 期
Promotion of Rotator Cuff Healing After Arthroscopic Rotator Cuff Repair Using Granulocyte Colony-forming Stimulating Factor - G-CSF for Promotion of Rotator Cuff Healing
Shitara Hitoshi0 个研究点目标入组 15 人开始时间: 2022年5月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 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
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 65age old（—）
- 性别
- All
入选标准
- •(1) Between 20 and 65 years old.
- •(2) Subjects who have a diagnosed with rotator cuff tears.
- •(3) Subjects whose tears are classified as middle size tears and greater than that by the Cofield's classification.
- •(4) Subjects who are scheduled to undergo arthroscopic shoulder rotator cuff repair.
- •(5) Subjects who have given written consent to participate in this study.
排除标准
- •1) Subjects who are hypersensitive to the components of the study drug or other granulocyte colony-forming stimulating factor products.
- •2) Subjects with myelogenous leukemia in which the number of blasts in the bone marrow is not sufficiently reduced, and research subjects with myelogenous leukemia in which myeloid blasts are observed in the peripheral blood.
- •3) Subjects with a history of drug hypersensitivity.
- •4) Subjects with a predisposition to allergy.
- •5) Subjects who require continuous anticoagulant medication during the perioperative period.
- •6) Subjects with splenomegaly.
- •7) Subjects with complications or history of maliglant tumors.
- •8) Subjects who are pregnant.
- •9) Subjects who are lactating.
- •10) Subjects with a history of thrombosis.
- •11) Subjects with a history of coronary artery disease or cerebrovascular disease.
- •12) Subjects with cardiac, pulmonary, renal, or hepatic disease requiring treatment.
- •13) Subjects with abnormal laboratory values requiring treatment or close examination.
- •14) Subjects with autoimmune diseases.
- •15) Subjects with neurological diseases.
- •16) Subjects with uncontrolled hypertension (resting systolic > 160 mmHg or diastolic > 100 mmHg).
- •17) Subjects with uncontrolled hyperlipidemia (total cholesterol > 240 mg/dL, except for LDL-C < 140 mg/dL).
- •18) Subjects with diabetes mellitus requiring medication (fasting blood glucose > 125 mg/dL or anytime blood glucose > 200 mg/dL).
- •19) Subjects with complications or history ofinterstitial pneumonia.
- •20) Subjects with contraindications to MRI imaging.
- •21) Other subjects who are judged by a physician to be inappropriate for the subject.
研究者
相似试验
招募中
2 期
Enhancement of healing after arthroscopic rotator cuff repair by extracorporeal shock wave therapy.Rotator cuff tearJPRN-jRCTs032200097Kamiyama Masataka150
招募中
2 期
Enhancement of healing after arthroscopic rotator cuff repair by PFC-FD(Platelet-Derived Factor Concentrate Freeze Dry)Rotator cuff tearJPRN-jRCTs031220227SHITARA HITOSHI20
已完成
1 期
Arthroscopic rotator cuff repair: Trans-osseous versus anchor techniqueMusculoskeletal DiseasesPACTR202404475835971Menoufia University60
已完成
不适用
Post-op Rehabilitation's Influence on Tendon Healing & Clinical Outcomes Following Arthroscopic Rotator Cuff RepairRotator Cuff TearNCT00756015Washington University School of Medicine150
招募中
1 期
Five-step shoulder manipulation therapy for rotator cuff injury: a multi-center, randomized, single-blind, controlled clinical study.Rotator cuff injuryITMCTR2000003838Shanghai Municipal Hospital of Traditional Chinese Medicine