Deformity of the upper extremity (malunited fracture, early closure of the growth plate, congenital anomaly)
Conditions
Interventions
Surgery for deformity correction of the upper extremity using custom-made surgical guide and bone plate based on preoperative computer simulation with CT data
Sponsors
Osaka University
Nagoya University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Deformity of the upper extremity resulted from malunited fractures, growth plate disturbance and congenital anomaly that has each or both of the following conditions; i) Disturbance of the adjacent joint or joints (restricted range of motion, instability, pain and/or osteoarthritis of the joint) ii) Emotional distress and/or limited social activities by the unsightly appearance 2. The age at the informed consent is 10<= and <=75 years old for both genders. 3. The informed consent obtained from the patient his or herself (from the guardian when the patient is10<= and <15 years old and from the guardian and the patient his or herself when he or she is 15<= and <20 years old)
Exclusion criteria
Exclusion criteria: 1. Sever shortening of the bone that cannot be corrected at one time. 2. Coincidence of two or more deformities in one bone. 3. Coincidence of the forearm and upper arm deformities at the same side. 4. Patient aged 15<= and <20 years who need internal fixation across the growth plate. 5. Patient with deformity of the same bone at the opposite side. 6. Inappropriate candidate for general anesthesia. 7. Patient with active malignant tumor. 8. Patient who is pregnant or possibly pregnant. Patient who hope to be pregnant during her trial. 9. Patient who is administrated anticoagulant that cannot be interrupted for the operation 10. Patient with generalized infection. 11. Patient with hemorrhagic diathesis that inhibits surgery. 12. Patient with allergic reaction to the custom-made guide or its component. 13. Patient with allergic reaction to the custom-made bone plate or its component. 14. Patient who underwent surgery using custom-made surgical guide and bone plate before. 15. Patient who has metal implant in the upper extremity of the same side for the operation. 16. Patient who entered another clinical trial or trials within one month before the start of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum postoperative residual angle of deformity calculated from the radiographic measurements | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Deformity angles on plain radiographs 2. Radio-Ulnar discrepancy (only for the cases with a deformity/ deformities of the radius and/or ulna) 3. Radiographic bony union 4. Clinical evaluation #1. Range of motion of the adjacent joint #2. Instability of the adjacent joint #3. Pain evaluated by Visual Analogue Scale(VAS) #4. Grip strength #5.Patient based outcome measures (DASH score, Quick DASH score) #6. Patient satisfaction 5. Accuracy of the deformity correction evaluated using CT computer bone model 6. Easiness of the use of the guides and bone plate in surgery 7.Clinical evaluation (WBC count, CRP) 8. Adverse events | — |
Countries
Japan
Contacts
Public ContactTatsuhiro Tatsuhiro Hanai
Osaka University Graduate School of Medicine Department of Orthopaedic Surgery
Outcome results
None listed