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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019788
Receipt No. R000022858
Scientific Title Anatomical ACL reconstruction using intraoperative calcium phosphate-hybridization method
Date of disclosure of the study information 2015/11/14
Last modified on 2017/05/26

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Basic information
Public title Anatomical ACL reconstruction using intraoperative calcium phosphate-hybridization method
Acronym Anatomical ACL reconstruction using intraoperative calcium phosphate-hybridization method
Scientific Title Anatomical ACL reconstruction using intraoperative calcium phosphate-hybridization method
Scientific Title:Acronym Anatomical ACL reconstruction using intraoperative calcium phosphate-hybridization method
Region
Japan

Condition
Condition anterior cruciate ligament injury
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes KT side to side difference
Pivot Shift test
Crinical score
CT
MRI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Anatomical ACL reconstruction using intraoperative calcium phosphate-hybridization method
Interventions/Control_2 Coventional anatomical ACL reconstruction
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

Not applicable
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Anterior cruciate ligament injury
Key exclusion criteria 1. Patient having a skin disease
2. Patient having serious complications (heart disease, liver disease, renal disease)
3. Within five years before agreement day a patient with the past of the malignant tumor or the patient suspected to have it
4. The patient that during the pregnancy or the pregnancy is doubted
5. The patient who does not have ability for voluntary agreement
6. The patient that the acquisition of the written agreement is impossible
7. In addition, the patient who judged that the medical attendant was inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Mutsuzaki
Organization Ibaraki Prefectural University of Health Sciences
Division name Department of Orthopaedic Surgery
Zip code
Address 4669-2 Ami, Inashiki-gun, Ibaraki 300-0394
TEL 029-888-4000
Email mutsuzaki@ipu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotaka Mutsuzaki
Organization Ibaraki Prefectural University of Health Sciences
Division name Department of Orthopaedic Surgery
Zip code
Address 4669-2 Ami, Inashiki-gun, Ibaraki 300-0394
TEL 029-888-4000
Homepage URL
Email mutsuzaki@ipu.ac.jp

Sponsor
Institute Ichihara hospital
Institute
Department

Funding Source
Organization Ibaraki Prefectural University of Health Sciences
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
2015 Year 11 Month 14 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
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 14 Day
Last modified on
2017 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022858

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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