The safety and efficacy of autologous concentrated bone marrow grafting in the treatment of osteonecrosis and non-union

The safety and efficacy of autologous concentrated bone marrow grafting in the treatment of osteonecrosis and non-union - The safety and efficacy of autologous concentrated bone marrow grafting

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020940

Enrollment

Registered

2016-02-09

Start date

2016-02-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteonecrosis, non-union (not infected)

Interventions

1. Autologous concentrated bone marrow grafting (single use) 2.Administration of Teriparatide (weekly, 3 months) or usage of low-intensity pulsed ultrasound (daily, 3 months)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A) any one that meet the following; 1.femoral head osteonecrosis (Steinberg stage 0-3) 2.humeral head osteonecrosis (Cruess stage 1-3) 3.knee osteonecrosis (Koshino stage 1-3) 4.osteonecrosis of lunate (Lichtman stage 1-2) 5.other osteonecrosis (Ficat and Arlet stage 1-3) B) Patients over 20 years old C) Informed consent in writing by patient

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The safety (adverse event) at one year after intervention	—

Secondary

Measure	Time frame
The efficacy (new bone formation) at one year after intervention	—

Countries

Japan

Contacts

Public ContactTomokazu Yoshioka

University of Tsukuba Musculoskeletal System, Department of Orthopaedic Surgery, Faculty of Medicine, University of Tsukub

yoshioka@md.tsukuba.ac.jp029-853-3219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026