Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
研究概览
简要总结
The goal of this clinical trial is to compare the clinical effectiveness and safety of robot-assisted autonomous closed reduction versus traditional manual closed reduction in adult patients aged 18 to 80 years with acute, closed intertrochanteric femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association [AO/OTA] classification 31-A). The main question it aims to answer is:
Whether robot-assisted autonomous closed reduction can achieve a significantly higher rate of excellent and good bone fracture reduction compared to traditional manual reduction, as rigorously evaluated by low-dose computed tomography (CT) and a three-dimensional (3D) quantitative standard.
Researchers will compare the robot-assisted autonomous closed reduction group (intervention group) to the traditional manual closed reduction group (control group) to see if the robotic system significantly improves 3D anatomical reduction precision, reduces intraoperative fluoroscopy times and radiation doses, shortens operation times, and ultimately enhances long-term clinical hip functions and health-related quality of life.
Participants will be asked to do the following tasks:
Complete baseline medical screening, standard hip X-rays, and bilateral full-length thin-layer CT scans before the surgery.
Undergo a 1:1 randomized allocation after anesthesia to receive either robot-assisted autonomous closed reduction or traditional experience-based manual closed reduction, both followed by conventional proximal femoral intramedullary nailing internal fixation.
Receive post-operative low-dose CT scans before discharge or within 2 weeks after surgery to evaluate the fracture reduction quality.
Follow a standardized Enhanced Recovery After Surgery (ERAS) rehabilitation pathway and attend scheduled follow-up visits at 1, 3, and 6 months after the surgery to monitor bone healing, hip functions, and quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years, inclusive.
- •Male or female participants.
- •Acute, closed intertrochanteric femoral fracture.
- •AO/OTA classification 31-A intertrochanteric femoral fracture.
- •Fracture requiring closed reduction and proximal femoral intramedullary nailing.
- •Injury-to-surgery interval no more than 14 days.
- •Participant or legally authorized representative is fully informed about the study.
- •Written informed consent voluntarily provided by the participant or legally authorized representative.
排除标准
- •Open fracture.
- •Pathological fracture.
- •Old fracture with an injury-to-surgery interval greater than 14 days.
- •Multiple fractures.
- •Previous surgery involving the affected hip joint.
- •Deformity of the affected hip joint.
- •Severe osteoarthritis of the affected hip joint.
- •Significant neuromuscular disease affecting lower limb function.
- •Significant neuromuscular disease affecting postoperative rehabilitation.
- •Severe systemic comorbidity that makes the participant unable to tolerate anesthesia or surgery.
- •Severe organ dysfunction that makes the participant unable to tolerate anesthesia or surgery.
- •Pregnancy.
- •Lactation.
- •Cognitive impairment that prevents compliance with postoperative follow-up or rehabilitation protocols.
- •Active psychiatric illness that prevents compliance with postoperative follow-up or rehabilitation protocols.
- •Other condition that prevents compliance with postoperative follow-up or rehabilitation protocols.
- •Current participation in another clinical trial that may interfere with evaluation of this study's outcomes.
结局指标
主要结局
Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
时间窗: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery
Closed fracture reduction will be assessed on postoperative low-dose CT using a 3D quantitative grading system. Four dimensions will be graded as Excellent, Good, Fair, or Poor: displacement/shortening, angular deformity, rotational deformity, and medial/anterior cortical support. The thresholds are ≤3 mm/° for Excellent, \>3-5 mm/° for Good, \>5-10 mm/° for Fair, and \>10 mm/° for Poor, while cortical support is graded as positive, neutral, mild negative, or significant negative/step-off. The final grade will be the lowest grade across all dimensions, and the excellent/good rate is the percentage of participants with a final grade of Excellent or Good.
次要结局
- Total Operation Time Measured in Minutes(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Intraoperative Blood Loss Measured in Milliliters(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Change from Baseline in Hip Function Assessed by Harris Hip Score (HHS)(From baseline to 1 month, 3 months, and 6 months after surgery)
- Change from Baseline in Quality of Life Assessed by EQ-5D-5L Questionnaire(From baseline to 1 month, 3 months, and 6 months after surgery)
- Time to Radiographic Bone Healing Assessed by Standard Two-View X-Ray(From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery)
- Number of Intraoperative C-Arm Fluoroscopy Shots(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Robot-Assisted Reduction Planning and Execution Time Measured in Minutes in the Experimental Group(From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours)
- Incidence of Intraoperative Complications(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Incidence of Postoperative Complications(From completion of surgery to the occurrence of postoperative complications, assessed up to 6 months after surgery)
- Length of Hospital Stay Measured in Days(From hospital admission to hospital discharge, assessed up to 30 days)
- Radiographic Fracture Union Rate Assessed by Standard X-Ray(From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery)
- Incidence of Reoperation(From completion of surgery to reoperation assessment, assessed up to 6 months after surgery)