rheumatoid arthritis
Conditions
Interventions
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
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactYuichi Mochida
Yokohama City University Medical Center Center for Rheumatic Diseases
Outcome results
None listed