UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019788 |
|---|---|
| Receipt number | 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 09:57:25 |
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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
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
mutsuzaki@ipu.ac.jp
Sponsor or person
Institute
Ichihara hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022858
