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
- Conditions
- Osteonecrosis of the femoral head
- Registration Number
- JPRN-UMIN000020340
- Lead Sponsor
- Haruhiko Akiyama, Gifu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 64
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of collapse of the femoral head 24 months after administration of the investigational agent
- Secondary Outcome Measures
Name Time Method 1.Changes in collapse of the femoral head over time 2.The stage of osteonecrosis of the femoral head over time 3.The type of osteonecrosis of the femoral head over time 4.Assessment of bone regeneration 5.Changes in the Harris Hip Score over time 6.Changes in the UCLA Activity Score over time 7.Incidence of AEs and adverse reactions