新規整形外科デバイスの設計と検証：骨折固定および整復効率の向上：外科的転帰への影響を伴うランダム化比較試験

Traumatic long bone fractures require precise reduction and stable fixation to achieve optimal outcomes during open reduction and internal fixation (ORIF). Conventional bone-holding instruments are often associated with prolonged operative time, increased blood loss, reliance on surgical assistance, and higher complication rates. This study aimed to evaluate the clinical effectiveness of a newly designed orthopedic repositioning device in reducing operative time, intraoperative blood loss, postoperative pain, and complications compared with conventional ORIF techniques.

This randomized controlled clinical trial was conducted between 2023 and 2024. Adult patients aged 18-65 years with diaphyseal fractures of the femur, humerus, or tibia who underwent ORIF were enrolled. Patients were randomized into two groups: an intervention group using the novel repositioning device and a control group undergoing conventional ORIF. All surgeries were performed by a single orthopedic surgeon. The device consists of dual bone holders with a lengthening/shortening mechanism that allows controlled traction, angular correction, and plate insertion without device removal. Primary outcome measures included duration of surgery, intraoperative blood loss, postoperative pain assessed by the visual analog scale (VAS), transfusion requirement, and postoperative complications. Statistical analysis was performed using Student's t-test or Mann-Whitney U test for continuous variables and chi-square test for categorical variables, with significance set at p < 0.05.

A total of 58 patients were included in the final analysis (29 per group), with a mean age of 29.9 years and a predominance of male patients (77.6%). Use of the repositioning device was associated with significantly reduced intraoperative blood loss (p < 0.05), shorter surgical duration (p < 0.05), and lower postoperative pain scores (p < 0.05) compared with the control group. The need for blood transfusion was significantly lower in the intervention group (p < 0.001). Postoperative complications occurred in 28.6% of patients in the control group but were not observed in the device group (p = 0.002). No significant difference in hospital length of stay was detected between groups (p = 0.284). Patients were followed for up to 3 months postoperatively.

The novel orthopedic repositioning device improves surgical efficiency and safety in ORIF of long bone fractures by reducing operative time, blood loss, postoperative pain, and complication rates, supporting its clinical value as an effective adjunct for fracture reduction and stabilization.