Safety and effectiveness study of OIF/KX in long bone nounio
- Conditions
- nonunion in femur, tibia or humerus
- Registration Number
- JPRN-jRCT2080225010
- Lead Sponsor
- Osteopharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 8
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Absence of abnormality in graft site and surrounding<br>X-ray radiographic<br>Clinical cure
- Secondary Outcome Measures
Name Time Method other<br>Adverse events<br>Local clinical symptoms