Clinical trial on the efficacy and safety of corrective osteotomy for the upper extremity using custom-made surgical guide and bone plate (exploratory research) - Clinical trial of deformity correction of the upper extremity using custom- made surgical guide and bone plate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 10years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •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.