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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000030024
Receipt No. R000034285
Scientific Title Clinical application for treatment of fractures using autologous and/or allogenic bone screws
Date of disclosure of the study information 2017/11/18
Last modified on 2019/05/21

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Basic information
Public title Clinical application for treatment of fractures using autologous and/or allogenic bone screws
Acronym Clinical application for treatment of fractures using autologous and/or allogenic bone screws
Scientific Title Clinical application for treatment of fractures using autologous and/or allogenic bone screws
Scientific Title:Acronym Clinical application for treatment of fractures using autologous and/or allogenic bone screws
Region
Japan

Condition
Condition Osteochondral fracture, Scaphoid fracture, Factures similar to them
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical outcomes of osteosynthesis using autologous and/or allogenic bone screw, and to evaluate its effectiveness and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective and objective clinical score
Key secondary outcomes Image assessment (Plain X-ray, CT, MRI)
Arthroscopic assessment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Make bone screw from autologous and/or allogenic bone using a precision processing machine (non-medical equipment).
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
10 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who require osteosynthesis because of free osteochondral fragments within the joint due to intra-articular fracture or osteochodritis dissecans.
2. Patients who require osteosynthesis because of scaphoid fracture or similar type of fractures (small bone fractures).
Key exclusion criteria 1. Patients with skin disease or infection around the target site.
2. Patients with malignancy or the history of that.
3. Patients with mental disorder or disturbance of consciousness.
4. Patients with drug allergy.
5. Patients suffering from severe acute illness within 6 months from the day of surgery.
6. Patients with severe kidney/liver disease, heart disease, blood disease, endocrine disease.
7. Patients with extremely low nutritional status. (Alb < 2g/dl)
8. Pregnant women, Patients who may be pregnant, and breast-feeding patients.
9. Other patients who were judged inappropriate as subjects of this research by the research director of research sharing person.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shinji
Middle name
Last name Imade
Organization Shimane university, Faculty of medicine
Division name Department of orthopaedic surgery
Zip code 693-8501
Address 89-1, Enya, Izumo, Shimane, Japan
TEL 0853-20-2242
Email imades@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Shinji
Middle name
Last name Imade
Organization Shimane university, Faculty of medicine
Division name Department of orthopaedic surgery
Zip code 693-8501
Address 89-1, Enya, Izumo, Shimane, Japan
TEL 0853-20-2242
Homepage URL
Email imades@med.shimane-u.ac.jp

Sponsor
Institute Shimane university, Faculty of medicine, Department of orthopaedic surgery
Institute
Department

Funding Source
Organization Shimane university, Faculty of medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Shimane university institutional committee on ethics
Address 89-1, Enya, Izumo, Shimane, Japan
Tel 0853-20-2515
Email kenkyu@med.shimane-u.ac.jp

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 島根大学医学部附属病院(島根県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 18 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 Suspended
Date of protocol fixation
2006 Year 08 Month 09 Day
Date of IRB
2006 Year 09 Month 01 Day
Anticipated trial start date
2007 Year 01 Month 15 Day
Last follow-up date
2020 Year 02 Month 28 Day
Date of closure to data entry
2020 Year 03 Month 15 Day
Date trial data considered complete
2020 Year 03 Month 15 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 18 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034285

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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