Rheumatoid arthritis
Conditions
Interventions
Implantation of an artificial wrist joint
Sponsors
Hokkaido University Hospital Orthopedics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patient bearing rheumatoid arthritis applicable to the wrist arthrodesis except for the implantation of an aritifitial wrist joint.. (2)Patient at the score of less than 50 points by Wrist Scoring System by Figgie. (3)Patient at the grade of 4 or 5 by Larsen's score. (4)Patient at the age of 20 years old or more. (5)Patient who understands the contents of the informed consent form. (6)Patient who is able to sign on the informed consent form, or if not, patient who has a substitute for the signature.
Exclusion criteria
Exclusion criteria: (1)Patient who has previously experienced the the wrist joint arthropathy. (2)Patient who was diagnosed as neuropathic arthropathy. (3)Patient who has an evident or a possible infection in or around the wrist joint. (4)Patient who has a mental illness and is considered not to obey directions of the doctor. (5)Patient who is pregnant or possibly pregnant. (6)Patient who is considered not to receive aftercare by the directions of the doctor. (7)Patient who is participating in an another clinical study. (8)Patient who has been previously implanted with the test device NM002. (9)Patient in whom the test device is not expected to be fixed firmly due to poor volume of bone, or in whom functional recovery of the wrist is not expected due to difficulty of the reconstruction of tendon. (10)Patient who has experienced serious advers reaction(s) caused by bone cement, sach as decrease in blood pressure, shock, or pulmonary embolism. (11)Patient who is determined to be excluded from the study due to any reason by the study doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrist Scoring System by Figgie | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Adverse events X-ray findings Efficacy: THE DASH the JSSH version Visual Analogue Scale range of motion grip | — |
Countries
Japan
Contacts
Public ContactFujio Inage
Hokkaido University Center for Translational Research(Hokkaido Organization for Translational Research)
Outcome results
None listed