UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007468 |
|---|---|
| Receipt number | R000008811 |
| Scientific Title | Anterior subcutaneous ulnar nerve transposition with vascular pedicle preservation for cubital tunnel syndrome - randomized prospective study- |
| Date of disclosure of the study information | 2012/03/08 |
| Last modified on | 2012/03/08 11:10:27 |
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Basic information
Public title
Anterior subcutaneous ulnar nerve transposition with vascular pedicle preservation for cubital tunnel syndrome
- randomized prospective study-
Acronym
Anterior subcutaneous ulnar nerve transposition with vascular pedicle preservation for cubital tunnel syndrome
Scientific Title
Anterior subcutaneous ulnar nerve transposition with vascular pedicle preservation for cubital tunnel syndrome
- randomized prospective study-
Scientific Title:Acronym
Anterior subcutaneous ulnar nerve transposition with vascular pedicle preservation for cubital tunnel syndrome
Region
| Japan |
Condition
Condition
cubital tunnel syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of preserving collateral arteries on ulnar nerve blood flow following anterior subcutaneous transposition in patients with cubital tunnel
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
laser Doppler flowmeter
DASH score
Nerve conductive study
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
anterior subcutaneous ulnar nerve transposition with vascular pedicle preservation
Interventions/Control_2
anterior subcutaneous ulnar nerve transposition without vascular pedicle preservation
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
Patients diagnosed as cubital tunnel syndrome and have necessary of surgery.
Patients obtained informed consent for study.
Key exclusion criteria
Patients not obtained informed consent.
Patients who had previous surgery of elbow.
Patients who complicated other nerve disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Nakamura |
Organization
Shinshu Unversity shool of medicine.
Division name
Department of Orthopaedic surgery
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinshu Unversity shool of medicine.
Division name
Department of Orthopaedic surgery
Zip code
Address
TEL
0263-37-2659
Homepage URL
Sponsor or person
Institute
Department of Orthopaedic surgery
Shinshu Unversity shool of medicine
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
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
| 2012 | Year | 03 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
| 2012 | Year | 03 | Month | 08 | Day |
Last modified on
| 2012 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008811
