Clinical trial on the efficacy and safety of corrective osteotomy for the upper extremity using custom-made surgical guide and bone plate (exploratory research)
- Conditions
- Deformity of the upper extremity (malunited fracture, early closure of the growth plate, congenital anomaly)
- Registration Number
- JPRN-UMIN000014833
- Lead Sponsor
- Osaka University
- Brief Summary
Purpose: We aimed to prospectively verify the efficacy and safety of patient-matched surgical guides and implants in corrective osteotomy for deformities of the upper extremity so that they can be used as an advanced medical instrument. Method: We enrolled 16 patients with 17 upper extremity bone deformities. All cases underwent 3-D corrective osteotomy with patient-matched surgical guide and plate. While the primary outcome was assessment of the maximum deformity angle (MDA), secondary outcomes were to calculate the deformity angle on two-dimensional plain radiographs, 3-D error between preoperative planning and postoperative result, clinical status [range of motion, grip strength, and pain with the visual analog scale (VAS)], and self-reported function system using Disabilities of the Arm, Shoulder, and Hand (DASH). Results: The average MDA significantly improved from 25.5 degrees to 3.3 degrees (p < 0.001). The angular deformity of the normal side in two-directional radiographs was within 10 degrees in all cases. The correction error between the postoperative 3D bone model and planning was <1 degree and 1 mm. The range of motion of adjacent joints improved. Average VAS significantly reduced from 2.41 to 0.26 (p < 0.001). The ratio of grip strength to contralateral normal side was significantly increased from 78.1% to 90.74% (p < 0.001). The average DASH score significantly improved from 21.3 to 7.8 (p < 0.001). We reported no major complications related to the present surgery. Conclusions: Corrective osteotomy using the patient-matched surgical guide and plate could attain accurate correction and good functional recovery in the upper extremity. The novel 3-D corrective osteotomy could benefit patients with bone deformity and contribute to standardizing complicated surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The maximum postoperative residual angle of deformity calculated from the radiographic measurements
- Secondary Outcome Measures
Name Time Method 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