Sterilised 3D-PRINTed Bone Models in Addition to Conventional CT Imaging for Operative Visualisation in Complex Intra-articular Fracture Repair - A Multi-centre, Double-blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of articular surface reduction grading assessed by three-point scale
研究概览
简要总结
The purpose of this study is to compare the effectiveness of 3D-printed bone models in addition to CT imaging versus CT imaging alone on surgical quality and operation time for patients undergoing surgical repair of intra-articular fractures.
详细描述
Surgical fixation of intra-articular fractures is a technically demanding task that poses significant challenges to orthopaedic surgeons. Articular fragments may be comminuted, depressed, or impacted, and neighbouring soft tissue is often heavily compromised. Furthermore, aggressive surgical dissection is typically necessary to achieve adequate visualisation, and anatomical reduction often devitalises bone fragments and invites deep infection. The management of intra-articular fractures requires a well-designed preoperative plan and a skilfully executed surgical tactic to guarantee the best possible outcome. Multiplanar reformation (CT-MPR) and three-dimensional reconstruction (CT-3DR) are imaging techniques that have enhanced intraoperative visualisation, however, accurate analysis of complex fractures remains challenging.
3D printing is a rapidly developing, low-cost technology that is already being applied across numerous contexts in orthopaedics and traumatology. 3D printed bone models can be produced from digitised CT data in a matter of hours, providing a dimensionally accurate representation of the patient's skeleton which approximates real-life visual and tactile experiences. When used in preoperative planning, these models have shown to improve surgeon communication and shorten surgical duration. Despite positive early results, few clinical studies have studied the effect of 3D bone model use on surgical outcome. The purpose of this randomised controlled trial is to compare the effectiveness of intraoperatively utilised 3D bone models in addition to conventional CT imaging on reduction quality and surgical duration versus CT imaging alone for patients undergoing surgical fixation of complex intraarticular fractures.
Patients providing informed consent will be screened for eligibility. All eligible patients will be randomly assigned in a double-blind manner (participant and outcome assessor) to receive surgical fracture fixation with or without the addition of sterilised 3D-printed bone models to standard CT imaging for intraoperative visualisation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are randomly assigned to either one of the interventional arm and will not be informed of the randomisation result.
A blinded reviewer will assess the postoperative radiographs and surgical quality.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 years or older
- •with intra-articular fracture of the proximal or distal humerus, proximal ulna, proximal radius, distal femur, or proximal or distal tibia (pilon fracture)
- •requiring anticipated surgical repair of fracture
- •with pre-operative CT scan already available as part of routine assessment
排除标准
- •pathological fracture
- •multiple fractures requiring simultaneous or staged operations
- •fractures around the hip, pelvis and acetabulum, and any other fracture types not specified in the inclusion criteria
- •requiring surgery within 24 hours of admission
- •unable or unwilling to give consent to participate
结局指标
主要结局
Quality of articular surface reduction grading assessed by three-point scale
时间窗: Immediately post-operation
The quality of articular surface reduction will be rated by two surgeons blinded to intervention allotment assessing post-operative and intraoperative fluoroscopic images. The Kappa value will be recorded for inter-observer agreement between two observers (1. Perfect reduction, 2. Observable imperfections 1-2mm, 3. Significant imperfections \>2mm)
Skin to skin duration of surgery (minutes)
时间窗: Immediately post-operation
The skin to skin duration of the surgery will be recorded.
次要结局
- Total fluoroscopy time (seconds)(Immediately post-operation)
- Total length of skin incision (mm)(Immediately post-operation)
- Incidence of surgical complications(3 months post-operation)
- Intraoperative blood loss (mL)(Immediately post-operation)
- Total tourniquet time (minutes)(Immediately post-operation)
- Quality of articular surface reduction grading assessed by three-point scale(3 months post operation)
- Health-related quality of life measured by SF-12 Chinese (HK) version(3 months post-operation)
研究者
Dr. Christian Xinshuo Fang
Clinical Assistant Professor
The University of Hong Kong