The safety and efficacy of autologous concentrated bone marrow grafting in the treatment of osteonecrosis and non-unio
- Conditions
- osteonecrosis, non-union (not infected)
- Registration Number
- JPRN-UMIN000020940
- Lead Sponsor
- Department of Orthopaedics Surgery, Faculty of Medicine, University of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
A) a patient who is indicated to change the prescriptions of drugs for osteoporosis or steroid within 3 months (except dose reduction and withdrawal) B) a patient who is not candidates for Teriparatide C) a patient who is diabetes (HbA1C>9%) D) a patient who is arteriosclerosis obliterans E) a patient who is difficult to discontinue Warfarin F) Brinkman index>600 G) a patient who suffered cardiac infarction or brain infarction within 6 months H) a patient who suffered severe heart, liver, or renal dysfunction I) a patient who takes digitalis J) a patient who requires dialysis K) a patient who suffered or suspected malignancy within 5 years L) a patient who suffered hematological malignancy M) a patient who have 1 year to live N) a patient who suffered active infection O) systolic blood pressure < 90 mmHg within 2 weeks) P) Body weight < 40 kg (within 2 weeks) Q) a patient who suffered loss of marrow function (within 2 weeks) R) a patient who does not have voluntary consent S) a patient who is difficult to take informed consent in writing T) others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety (adverse event) at one year after intervention
- Secondary Outcome Measures
Name Time Method The efficacy (new bone formation) at one year after intervention