UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of surgical joint reconstructive procedure for treatment of patients with long-standing rheumatoid arthritis
Title of the study (Brief title)	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	Naoki Ishiguro
Organization	Nagoya Univeristy Graduate School of Medicine
Division name	Orthopedic Surgery
Address	65 Tsrumai, Showa, Nagoya, Aichi, Japan
TEL	052-744-1908
Email	n-ishi@med.nagoya-u.ac.jp

Public contact
Name of contact person	Toshihisa Kojima
Organization	Nagoya University Hospital
Division name	Orthopedic Surgery
Address	65 Tsrumai, Showa, Nagoya, Aichi, Japan
TEL	052-744-1908
Homepage URL
Email	toshik@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

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

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 09 Month 24 Day
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

Related information
URL releasing protocol	http://www.med.nagoya-u.ac.jp/
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014793