UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004413
Receipt number 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 15:30:27

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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 or person

Institute

Yokohama City University Medical Center

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


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

Value
https://center6.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