UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032206 |
|---|---|
| Receipt number | R000036669 |
| Scientific Title | Utility of rotational infraspinatus muscle transfer for irreparable massive rotator cuff tears. |
| Date of disclosure of the study information | 2018/04/12 |
| Last modified on | 2019/04/30 10:27:55 |
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Basic information
Public title
Utility of rotational infraspinatus muscle transfer for irreparable massive rotator cuff tears.
Acronym
Utility of rotational infraspinatus muscle transfer
Scientific Title
Utility of rotational infraspinatus muscle transfer for irreparable massive rotator cuff tears.
Scientific Title:Acronym
Utility of rotational infraspinatus muscle transfer
Region
| Japan |
Condition
Condition
rotator cuff tears
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate postoperative results and complications of the rotational infraspinatus muscle transfer for irreparable massive rotator cuff tears.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of tendon heeling at 3 months after surgery by magnetic resonance imaging
Key secondary outcomes
The shoulder range of motion, functional assessments(JOA score, UCLA score, VAS scale) and self-reporting scales(Simple shoulder test, Quick-DASH score, WORC index) at preoperative and 3, 6, 12, 24 months after surgery were assesed.
The muscle strength atpreoperative and 3, 6, 12, 24 months after surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
rotational infraspinatus muscle transfer
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who had a diagnosis of rotator cuff tear by MRI
2) Tear size of the rotator cuff was > 5cm by MRI
3) Patients had not severe cuff tear arthropathy(Hamada grade 1 or 2)
Key exclusion criteria
1) Patients who had progression of the osteoarthritis changes including rheumatoid arthritis
2) Patients had severe cuff tear arthropathy(Hamada grade 3 or 4)
3) Exogenous disease such as trauma, nerves, myopathy, congenital anomaly
4) Patients who had cervical spondylosis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Minamikawa |
Organization
Fukuoka University Chikushi Hospital
Division name
Dept. of Orthop. Surg
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL
092-921-1011
tomominamikawa@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Minamikawa |
Organization
Fukuoka University Chikushi Hospital
Division name
Dept. of Orthop. Surg
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL
092-921-1011
Homepage URL
tomominamikawa@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Fukuoka University Chikushi Hospital
Address
1-1-1, Zokumyoin, Chikushino, Fukuoka
Tel
092-921-1011
chikushirinsho@adm.fukuoka-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 12 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036669
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
