UMIN-CTR Clinical Trial

Basic information
Public title	The safety and efficacy of autologous concentrated bone marrow grafting in the treatment of osteonecrosis and non-union
Acronym	The safety and efficacy of autologous concentrated bone marrow grafting
Scientific Title	The safety and efficacy of autologous concentrated bone marrow grafting in the treatment of osteonecrosis and non-union
Scientific Title:Acronym	The safety and efficacy of autologous concentrated bone marrow grafting
Region	Japan

Condition
Condition	osteonecrosis, non-union (not infected)
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluated a novel form of treatment of osteonecrosis and non-union, in which autologous concentrated bone marrow grafting using a bone marrow concentrate was followed by Teriparatide or LIPUS.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	The safety (adverse event) at one year after intervention
Key secondary outcomes	The efficacy (new bone formation) at one year after intervention

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	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)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hajime Mishima
Organization	University of Tsukuba
Division name	Department of Orthopaedics Surgery, Faculty of Medicine
Zip code
Address	1-1-1 Tennodai,Tsukuba, Ibaraki, Japan
TEL	029-853-3219
Email	hmishima@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomokazu Yoshioka
Organization	University of Tsukuba
Division name	Musculoskeletal System, Department of Orthopaedic Surgery, Faculty of Medicine, University of Tsukub
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3219
Homepage URL
Email	yoshioka@md.tsukuba.ac.jp

Sponsor
Institute	Department of Orthopaedics Surgery, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	Division of Regenerative Medicine for Musculoskeletal System, Department of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 09 Day
Date of IRB	2016 Year 01 Month 13 Day
Anticipated trial start date	2016 Year 02 Month 09 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2018 Year 09 Month 30 Day
Date analysis concluded	2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 02 Month 08 Day
Last modified on	2022 Year 08 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024155