UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012649 |
|---|---|
| Receipt number | R000014793 |
| Scientific Title | Evaluation of surgical joint reconstructive procedure for treatment of patients with long-standing rheumatoid arthritis |
| Date of disclosure of the study information | 2013/12/24 |
| Last modified on | 2019/02/20 16:15:11 |
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Basic information
Public title
Evaluation of surgical joint reconstructive procedure for treatment of patients with long-standing rheumatoid arthritis
Acronym
Surgical joint reconstructive procedure for long-standing rheumatoid arthritis patients
Scientific Title
Evaluation of surgical joint reconstructive procedure for treatment of patients with long-standing rheumatoid arthritis
Scientific Title:Acronym
Surgical joint reconstructive procedure for long-standing rheumatoid arthritis patients
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the 1) relationship between disability of each joint and physical function, 2) assistive action in activity of daily life, 3) effectiveness of joint reconstructive surgery on improvement of physical function in daily life as well as patient-reported outcome in long-standing patients with rheumatoid arthritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of 1)physical function of daily life(HAQ-DI, DASH, lower limbs function),2) QOL(EQ-5D), and 3)depression severity by joint reconstructive surgery
Key secondary outcomes
Baseline evaluation
1) Disability of long-standing RA patients who required joint reconstructive surgery
2) Relationship between range of motion of each joint and disability of daily life
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
Patients with rheumatoid arthritis who required joint reconstructive surgery and who understand the meanings of this study and consent to participation to this study.
Key exclusion criteria
Patients
1) who have other diseases than rheumatoid arthritis which remarkable impacts on outcome measurement of this study
2) who cannot answer the questionnaires by themselves. (In case the patients who cannot answer them only by physical disability, have someone to support them, they can participate the study.)
3) who are considered not to fit to participate this study by physician.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Ishiguro |
Organization
Nagoya Univeristy Graduate School of Medicine
Division name
Orthopedic Surgery
Zip code
Address
65 Tsrumai, Showa, Nagoya, Aichi, Japan
TEL
052-744-1908
n-ishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihisa Kojima |
Organization
Nagoya University Hospital
Division name
Orthopedic Surgery
Zip code
Address
65 Tsrumai, Showa, Nagoya, Aichi, Japan
TEL
052-744-1908
Homepage URL
toshik@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Orthopedic Surgery, National Hospital Organization Minami Osaka Medical Centre,
Department of Human Morphology, Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences,
Department of Orthopedic Surgery, Keio University School of Medicine,
Department of Rehabilitation, Keio University School of Medicine,
Department of Orthopedic Surgery, National Hospital Organization Kyushu Medical Centre,
Department of Orthopedic Surgery, Saitama Medical University,
Department of Orthopaedic Surgery and Spinal Surgery, The University of Tokyo Hospital,
Departm
Name of secondary funder(s)
None
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
名古屋大学病院（愛知県）
大阪南医療センター(大阪府)
岡山大学病院 （岡山県）
慶応大学病院 （東京都）
九州医療センター（福岡県）
埼玉医科大学病院 （埼玉県）
東京大学病院（東京都）
東京女子医大リウマチ
痛風センター
（東京都）
富山大学病院（富山県）
新潟県立リウマチセンター
（新潟県）
行岡病院 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
http://www.med.nagoya-u.ac.jp/
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1. Kojima T, Ishikawa H, Tanaka S, Haga N, Nishida K, Yukioka M, Hashimoto J, Miyahara H, Niki Y, Kimura T, Oda H, Asai S, Funahashi K, Kojima M, Ishiguro N. Characteristics of functional impairment in patients with long-standing rheumatoid arthritis based on range of motion of joints: Baseline data from a multicenter prospective observational cohort study to evaluate the effectiveness of joint surgery in the treat-to-target era. Mod Rheumatol. 2018;28(3):474-81.
2. Kojima T, Ishikawa H, Tanaka S, Haga N, Nishida K, Yukioka M, Hashimoto J, Miyahara H, Niki Y, Kimura T, Oda H, Asai S, Funahashi K, Kojima M, Ishiguro N. Validation and reliability of the Timed Up and Go test for measuring objective functional impairment in patients with long-standing rheumatoid arthritis: a cross-sectional study. Int J Rheum Dis. 2018;21(10):1793-800.
3. Kojima T, Ishikawa H, Tanaka S, Haga N, Nishida K, Yukioka M, Hashimoto J, Miyahara H, Niki Y, Kimura T, Oda H, Asai S, Funahashi K, Kojima M, Ishiguro N. Target setting for lower limb joint surgery using the Timed Up and Go test in patients with rheumatoid arthritis: A prospective cohort study. Int J Rheum Dis. 2018;21(10):1801-8.
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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
We will explore relationship between improvement of physical function and patient-reported outcome by joint reconstructive surgery, additionally.
Management information
Registered date
| 2013 | Year | 12 | Month | 21 | Day |
Last modified on
| 2019 | 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=R000014793
