UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002190 |
|---|---|
| Receipt number | R000002688 |
| Scientific Title | Optimal insertion angle for suture anchors-An assessment using three dimensional finite element method |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2015/07/14 04:03:57 |
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Basic information
Public title
Optimal insertion angle for suture anchors-An assessment using three dimensional finite element method
Acronym
Optimal insertion angle for suture anchors
Scientific Title
Optimal insertion angle for suture anchors-An assessment using three dimensional finite element method
Scientific Title:Acronym
Optimal insertion angle for suture anchors
Region
| Japan |
Condition
Condition
Rotator cuff tears
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Suture anchors have been used as the standard device in the rotator cuff repair. However, neither the optimal angle nor interval in their insertion have not been clarified yet. The purpose of this study is to clarify the optimal insertion technique of suture anchors biomechanically.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The failure load of the inserted anchors into the humral head will be calculated using 3-dimensional finite element method, which will be then compared between various insertion angles or intervals.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The rotator cuff tear patients, who are scheduled for the surgical repair.
Key exclusion criteria
The patients who do not want to participate this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Sano |
Organization
Tohoku University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-1 Seiryo-machi, Aobaku, Sendai, Japan
TEL
022-717-7245
sanohirotaka@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Sano |
Organization
Tohoku University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-1 Seiryo-machi, Aobaku, Sendai, Japan
TEL
022-717-7245
Homepage URL
sanohirotaka@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Tohoku University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 08 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
The suture anchors will be inserted in the finite element model of the patient's humeral head. Both the pattern of stress distribution the failure load will be calculated and compared between various insertion angles or intervals.
Management information
Registered date
| 2009 | Year | 07 | Month | 13 | Day |
Last modified on
| 2015 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002688
