The effects of modified surgical instrument on bone remodeling and bone mass after artificial toe implants.
Not Applicable
- Conditions
- rheumatoid arthritis
- Registration Number
- JPRN-UMIN000004413
- Lead Sponsor
- Yokohama City University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA).
- Secondary Outcome Measures
Name Time Method 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.