UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020940
Receipt number R000024155
Scientific Title The safety and efficacy of autologous concentrated bone marrow grafting in the treatment of osteonecrosis and non-union
Date of disclosure of the study information 2016/02/09
Last modified on 2022/08/15 08:00:02

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024155


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name