UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of modified surgical instrument on bone remodeling and bone mass after artificial toe implants.
Title of the study (Brief title)	The effects of modified surgical instrument in artificial toe implants.
Region	Japan

Condition
Condition	rheumatoid arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze the effects of modified surgical instrument on bone remodeling and bone mass after artificial toe implants.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA).
Key secondary outcomes	Disease Activity Score (The european League against rheumatism), Foot and ankle score (Japanese Orthopaedic Association), Radiological assessments of bone around the artificial implants by plain radiographs and Computed Tomography.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Conventional surgical instrument (old rasp) group: Surgery will be performed using conventional surgical instrument (old rasp).
Interventions/Control_2	Modified surgical instrument (new rasp) group: Surgery will be performed using modified surgical instrument (new rasp).
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 be diagnose as rheumatoid arthritis and fulfill the classification criteria by American Collage of Rheumatology. 2) Patients who will be diagnose as class 2 or higher by classification criteria by Steinblocker. 1.Completely able to perform usual activities of daily living (self-care, vocational, and avocational) 2. Able to perform usual self-care and vocational activities, but limited in avocational activities 3. Able to perform usual self-care activities, but limited in vocational and avocational activities 4. Limited in ability to perform usual self-care, vocational, and avocational activities 3) Patients who has involved lesion of the forefoot by rheumatoid arthritis with Larsen grade 2 or more, and fulfill prosthetic adaptation. (Age limit: 20 years old or older) 4.) Patients who is treated medical therapy enough, and overall status may be worthy of surgery. (Performance Status 0-1 cases) 5.) Patients who has no history of index surgery for the same toe. 6) Patients whose written agreement is obtained for participation in this study.
Key exclusion criteria	1) The patients who has the allergy to metal (titanium) or silicon. 2) The patients with serious complications (such as arrhythmia / acute pneumonia / various general infectious diseases / bleeding tendencies with a history / the treatment of the myocardial infarction within heart failure / coronary insufficiency within 6 months). 3) The patient under treatment of the mental disorder. 4) The patient that a study responsibility physician judged to be inappropriate.
Target sample size	60

Research contact person
Name of lead principal investigator	Yuichi Mochida
Organization	Yokohama City University Medical Center
Division name	Center for Rheumatic Diseases
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	ymochi@yokohama-cu.ac.jp

Public contact
Name of contact person	Yuichi Mochida
Organization	Yokohama City University Medical Center
Division name	Center for Rheumatic Diseases
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	ymochi@urahp.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 10 Month 20 Day
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 10 Month 19 Day
Last modified on	2017 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005272