Unique ID issued by UMIN | UMIN000004413 |
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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 |
The effects of modified surgical instrument on bone remodeling and bone mass after artificial toe implants.
The effects of modified surgical instrument in artificial toe implants.
The effects of modified surgical instrument on bone remodeling and bone mass after artificial toe implants.
The effects of modified surgical instrument in artificial toe implants.
Japan |
rheumatoid arthritis
Clinical immunology |
Others
NO
To analyze the effects of modified surgical instrument on bone remodeling and bone mass after artificial toe implants.
Bio-equivalence
Confirmatory
Pragmatic
Not applicable
Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA).
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Device,equipment |
Conventional surgical instrument (old rasp) group: Surgery will be performed using conventional surgical instrument (old rasp).
Modified surgical instrument (new rasp) group: Surgery will be performed using modified surgical instrument (new rasp).
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
60
1st name | |
Middle name | |
Last name | Yuichi Mochida |
Yokohama City University Medical Center
Center for Rheumatic Diseases
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
ymochi@yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Yuichi Mochida |
Yokohama City University Medical Center
Center for Rheumatic Diseases
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
ymochi@urahp.yokohama-cu.ac.jp
Yokohama City University Medical Center
None
Self funding
NO
横浜市立大学附属市民総合医療センター(神奈川県)
2010 | Year | 11 | Month | 01 | Day |
Unpublished
Terminated
2010 | Year | 10 | Month | 20 | Day |
2010 | Year | 11 | Month | 01 | Day |
2017 | Year | 10 | Month | 31 | Day |
2010 | Year | 10 | Month | 19 | Day |
2017 | Year | 04 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005272
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