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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004413
Receipt No. R000005272
Scientific Title The effects of modified surgical instrument on bone remodeling and bone mass after artificial toe implants.
Date of disclosure of the study information 2010/11/01
Last modified on 2017/04/28

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Basic information
Public title The effects of modified surgical instrument on bone remodeling and bone mass after artificial toe implants.
Acronym The effects of modified surgical instrument in artificial toe implants.
Scientific Title The effects of modified surgical instrument on bone remodeling and bone mass after artificial toe implants.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuichi Mochida
Organization Yokohama City University Medical Center
Division name Center for Rheumatic Diseases
Zip code
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
1st name
Middle name
Last name Yuichi Mochida
Organization Yokohama City University Medical Center
Division name Center for Rheumatic Diseases
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2010 Year 10 Month 20 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000005272

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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