nonunion in femur, tibia or humerus
Conditions
Interventions
investigational material(s)
Generic name etc : Recombinant human BMP-2
INN of investigational material : -
Therapeutic category code : 49- Other agents affecting cellular function
Dosage and Administr
Sponsors
Osteopharma Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The subject is 20 to 70 years old (when obtaining informed consent) 2. Patients with nonunion fracture in femur, tibia, or hummerus have been in nonunion for more 6 months since the fracture injury or the previous nonunion surgery, and need the surgery of autologous bonegraft. 3. Patients who are categorized to noninfected nonunion or non drainage and non active infected nonunion in Muller classification. 4. Patients who have general condition enough to undergo surgery, and are permitted to participate in the clinical study by investigator. 5. Patients who can understand the informed consent form and are willing to provide signature.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if ANY of the following exclusion criteria apply 1.Congenital pseudoarthrosis 2.Multiple pseudoarthrosis 3.Under radiation therapy, chemical therapy, or taking immunosuppressant 4.With movement paralysis in upper limb or lower limb of treatment (paralysis in lower limbs due to cerebral infarction, spinal cord injury, etc.) 5.Allergy or hypersensitive to calcium phosphatic 6.Malignant tumor or less than 5 years recurrence period after cancer treatment 7.Diabetes with uncontrollable blood glucose level medically by judgement of doctor. 8.Unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage or transient ischemic attack less than 3 months after onset 9.Severe liver, renal, or heart disease 10.Autoimmune disease or history (excluding Hashimoto's thyroiditis or Graves'disease) 11.Patients who had or will have any other surgery on same extremity of nonunion within 30 days of nonunion surgery (exclude osteomyelitis, or external fixation removal) 12.Patients who participate in other clinical study (investigational product or device) at the enrollment 13.Registered in this clinical study in the past 14.Patients with Alcohol dependence or drug dependence 15.Any condition that is not suitable to participate in the study based on the physician's judgement. 16.Patients who have difficulty in the examination or follow-up designed in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Absence of abnormality in graft site and surrounding X-ray radiographic Clinical cure | — |
Secondary
| Measure | Time frame |
|---|---|
| other Adverse events Local clinical symptoms | — |
Countries
Japan
Outcome results
None listed