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
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
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
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
