JPRN-UMIN000020340已完成2 期
A multicenter, investigator-initiated phase II clinical trial involving administration of a cross-linked gelatin hydrogel containing recombinant human basic fibroblast growth factor (rh-bFGF) to prevent the collapse of the femoral head - A clinical trial for idiopathic osteonecrosis of femoral head using trafermin (genetical recombination) gelatin hydrogel to evaluate the effectiveness and the safety (TRION)
Haruhiko Akiyama, Gifu University Hospital0 个研究点目标入组 64 人开始时间: 2015年12月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
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
- 15years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Preoperatively, a plain CT scan of the hip reveals cracks in subchondral bone in the femoral head or disruption of the continuity of the femoral head and neck. 2) Patients with a tumor or tumor-like condition, epiphyseal dysplasia, trauma (e.g. femoral neck fracture or traumatic dislocation of the hip), or slipped capital femoral epiphysis, patients receiving pelvic radiation, patients with decompression sickness and osteonecrosis of the femoral head, and patients with Perthes disease. 3) Patients who were diagnosed with osteonecrosis of the femoral head and who previously underwent this surgery. 4) Patients with a BMI of 30 or greater. 5) Patients with any of the following conditions: *Conditions that could pose major obstacles to the conduct of this trial (poorly controlled diabetes, hypertension, severe heart disease, respiratory disease, renal failure, hepatic failure, etc.) *Patients with a malignancy who have been disease-free for less than 5 years (However, carcinoma in situ and intramucosal carcinoma are not included in active malignancies) *Patients with a psychiatric disorder or psychiatric symptoms that would preclude participation in this trial *Patients with an active infection that would pose a problem clinically. 6) Patients being treated for diabetic retinopathy. (pre-proliferative diabetic retinopathy or proliferative diabetic retinopathy). 7) Patients with a previous history of any of the following: *A gelatin allergy *Patients with a drug allergy or other condition that would pose a problem during this trial. 8) Patients requiring continuous systemic administration of steroids (a dose exceeding an equivalent prednisolone dose of 15 mg/day). 9) Women who are or may be pregnant. Women who are nursing. Men or women who do not consent to use of contraception during this trial. 10) Other individuals whom an investigator or sub-investigator deems inappropriate for participation in this trial.
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