UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031395 |
|---|---|
| Receipt number | R000035844 |
| Scientific Title | The prospective cohort study of the change of physical activity through the surgical treatment for ankle osteoarthritis patients |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/02/20 19:26:57 |
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Basic information
Public title
The prospective cohort study of the change of physical activity through the surgical treatment for ankle osteoarthritis patients
Acronym
The change of physical activity through the surgical treatment for ankle osteoarthritis patients
Scientific Title
The prospective cohort study of the change of physical activity through the surgical treatment for ankle osteoarthritis patients
Scientific Title:Acronym
The change of physical activity through the surgical treatment for ankle osteoarthritis patients
Region
| Japan |
Condition
Condition
ankle osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the effectiveness of surgical treatment for the ankle osteoarthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
number of steps
Key secondary outcomes
activity duration
pain visual analogue scale
Japanese Society for Surgery of the Foot standard rating system
Self- Administered Foot Evaluation Questionnaire
expectation and satisfaction for operation
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
| Behavior,custom |
Interventions/Control_1
activity monitor for 1 week
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
1. patients who will have ankle arthrodesis or ankle arthroplasty for ankle osteoarthritis
2. patients who agree with this study through precise instruction and understanding
Key exclusion criteria
1. the past history of foot and ankle operations
2. neuromuscular disease
3. inflammation disease
4. complications which affect physical activity
5. patients who cannot answer the questionnaire
6. daily use of wheel chair
7. revision case
8. patients who reject to participate in this study
9. patients whom a principal investigator assessed as inadequate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Kanzaki |
Organization
Kobe university graduate school of medicine
Division name
Orthopaedic surgery
Zip code
Address
7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe city
TEL
078-382-5985
kanzaki@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Kanzaki |
Organization
Kobe university graduate school of medicine
Division name
Orthopaedic surgery
Zip code
Address
7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe city
TEL
078-382-5985
Homepage URL
kanzaki@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University, Teikyo University Hospital, Mizonokuchi, Kurume University, St Lukes International Hospital, Hyakutake orthopaedics and Sports Clinic
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
千葉大学(千葉県、Chiba University)、帝京大学医学部付属溝口病院(神奈川県、Teikyo University Hospital, Mizonokuchi)、久留米大学(福岡県、Kurume University)、聖路加国際病院(東京都、St. Luke’s International Hospital)、百武整形外科スポーツクリニック(佐賀県、Hyakutake Orthopaedics and Sports Clinic)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
| 2018 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
| 2018 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035844
