Osteonecrosis of the femoral head
Conditions
Interventions
Gelatin hydrogel containing 800 ug of trafermin (genetical recombination)
Sponsors
Haruhiko Akiyama, Gifu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Osteonecrosis of the femoral head meets the diagnostic criteria for that condition and is Stage 1 or Stage 2. 2) Osteonecrosis of the femoral head is Type C1 or C2 depending on the location of necrosis. 3) A gelatin hydrogel can be administered to the necrotic region in the affected femur (guide pins are able to reach the necrotic portion of the femoral head). 4) Patients are ages 15 to 75 when they consent to participate in this trial. 5) The patient is able to provide consent to participate in this trial in writing. If the patient is a minor, the consent of the patient and his/her representative (guardian) is required.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of collapse of the femoral head 24 months after administration of the investigational agent | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYutaka Kuroda
Kyoto University Hospital Department of Orthopaedic Surgery
Outcome results
None listed