UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015304 |
|---|---|
| Receipt number | R000017803 |
| Scientific Title | A prospective study of the modified Sauve-Kapandji procedure with and without stabilization of the proximal ulnar stump |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2014/10/01 12:46:35 |
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Basic information
Public title
A prospective study of the modified Sauve-Kapandji procedure with and without stabilization of the proximal ulnar stump
Acronym
Stabilization of proximal ulnar stump
Scientific Title
A prospective study of the modified Sauve-Kapandji procedure with and without stabilization of the proximal ulnar stump
Scientific Title:Acronym
Stabilization of proximal ulnar stump
Region
| Japan |
Condition
Condition
Radio-ulnar joint arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether stabilization by the extensor carpi ulnaris tendon contributed to the ulnar stump becoming stable and less painful
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain, ROM, power, radiogram
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
Stabilization of the proximal ulnar stump by the extensor carpi ulnaris
Interventions/Control_2
No stabilization of the proximal ulnar stump
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with the distal radioulnar arthritis needed surgical intervention
Key exclusion criteria
1. No mental returdation
2. Cooperative patient for treatment and evaluation
3. No hand or neurological disorders without distar radioulnar arthritis
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Kanaya |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
Address
South1, West 16, Chuo-ku, Sapporo
TEL
011-611-2111
kokanaya@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Kanaya |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
Address
South1, West 16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
kokanaya@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School 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
| 2014 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2014 | Year | 10 | Month | 01 | Day |
Last modified on
| 2014 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017803
