Customized Bone Allografts by Virtual Surgical Planning and 3D-printing for Correcting Musculoskeletal Deformities in Children
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- allograft dimensions
研究概览
简要总结
Virtual surgical planning (VSP), the simulation of bone corrections in virtual reality ("Computer Aided Surgical Simulation": CASS) and 3D printing of customized implants and devices are achieving an increasingly central role in clinical practice and orthopaedic surgery.
Those technologies and processes allow an allow incredibly versatile and accurate planning and reproduction of complex bone correction or joint replacement procedures.
Recent and converging evidence document how the use of these technologies is able to significantly reduce surgical times, bleeding and intra-operative complications, and the use of intra-operative fluoroscopy.
Due to the collaboration between the ward of Pediatric Orthopedics and Traumatology of the Rizzoli Orthopedic Institute and the Department of Industrial Engineering (DIN) of the University of Bologna it was possible to experiment, validate and introduce simulation, planning and personalization technologies of interventions of corrective surgery of Musculoskeletal Disorders (MSDs) of the limbs in childhood and developmental age into clinical practice. (3D-MALF - CE AVEC: 356/2018/Sper/IOR).
Currently, extremely complex bone correction interventions are often planned and performed through Computer Aided Design (CAD) and 3D printing of models and custom sterilizable cutting guides (Patient-Specific Instrument, PSI).
In pediatric orthopedic surgery is often necessary to use homologous massive bone grafts customized on the patient's anatomy, which can be employed in the replacement of neoplastic lesions, in the axial correction of deformities or even in the extemporaneous lengthening of bone segments.
The Musculoskeletal Tissue Bank (BTM) regularly provides bone grafts processed in a Class A controlled contamination environment according to GMP (Clean Room), guaranteeing quality and microbiological safety. The current realization standard of bone grafts on specific request is a freehand realization. The BTM technicians model the grafts, based on the indications received (length, width, height, indications on geometry), using standard surgical instruments (osteotomes, oscillating saws, etc.).
The present clinical trial aims to validate the feasibility, accuracy and effectiveness of an innovative process for producing customized bone allografts to correct bone deformities in children. the customization process will be conducted by using computer-aided surgical simulation and 3D printing.
详细描述
The study is a double-blind randomized clinical trial and point to achieve a comparison of geometry and use in the operating room between manually modelled bone grafts and bone grafts modelled using CAD techniques and customized cutting guides realized with 3D printing.
In addition, two other objectives will be pursued: (1) to conduct a preliminary analysis of the management and production costs of customized bone grafts and of the generation process using VSP and 3D printing of models and surgical interventions aids such as sterilizable PSI and GSI; (2) to treat pediatric patients suffering from congenital malformations that require complex multiplanar, multifocal and/or multisegmental bone correction surgery planning the intervention using VSP and implanting bone grafts produced by BTM with the aid of sterilizable PSI made by 3D printing.
The study involves the creation of a clinical-surgical path, divided into various consecutive steps implemented in part by PED-IOR, by BTM-IOR, by DIN-UNIBO and by Diagnostic and Interventional Radiology (RAD-IOR).
The process begins with the selection of the patient for the study by PED-IOR. After a clinical evaluation of the patient and the definition of the underlying pathology and deformity to be treated, if the patient complies with the inclusion criteria, a hypothesis of treatment and a choice of surgical technique is identified. Then, the path is illustrated to the patient and the family, also for the purpose of acquiring a written informed consent.
Once the patient is enrolled, the path includes the radiological study of the patient by RAD-IOR. As normal clinical practice requires, the bone segments will first be examined by panoramic x-rays with any comparatives of the contralateral limb, then the pre-operative CT scan at very low radiation dose will be performed.
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, Care Provider)
盲法说明
Both the doctor and the patient will not be aware of the graft preparation method.
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From 2 to 18 years old
- •Diagnosis of limbs musculoskeletal diseases
- •Need for uni- or poly-axial correction through one or more osteotomies
- •Need for massive bone graft to stabilize the correction
- •Consent to the processing of data
排除标准
- •Patients who refuse the VSP study
- •Patients who do not undergo in-depth radiological examinations or patients with insufficient radiological documentation
- •Patients who undergo different interventions for the correction of musculoskeletal disease
- •Patients who do not need a massive bone graft
- •Pregnant women
结局指标
主要结局
allograft dimensions
时间窗: The measurements will be collected during the first three years of the study.
The main dimensions of the obtained graft (height, lenght and depth), which are also the most clinically significant, will be measured in millimiters in the clean-room. The analysis of the dimensions obtained will be performed reconstructing the CT images of the graft. These dimensions will be compared with those planned by VSP, in order to examine the accuracy, reliability, and repeatability of the graft processing through GSI compared to standard processing.
allograft volume
时间窗: The measurements will be collected during the first three years of the study.
The volume of the obtained graft will be measured in millimiters square in the clean-room. The analysis of the volumes obtained will be performed reconstructing the CT images of the graft. These values will be compared with those planned by VSP, in order to examine the accuracy, reliability, and repeatability of the graft processing through GSI compared to standard processing.
次要结局
- Fluoroscopy time(The analysis will be conducted during the first three years of the study.)
- cost analysis(The cost analysis will be conducted during the first three years of the study.)
- Geometrical-structural analysis of PSI and GSI(The geometrical-structural analysis will be conducted during the first three years of the study.)
- operating time(The analysis will be conducted during the first three years of the study.)
- Intraoperative bleeding(The analysis will be conducted during the first three years of the study.)
- Peri-operative complications(The analysis will be conducted during the first three years of the study.)
- Degree of correction(The analysis will be conducted during the first three years of the study.)
- Paediatric Outcome Data Collection Instrument (PODCI)(this evaluation will be conducted during the first three years of the study.)
- additional surgeries(this evaluation will be conducted during the first three years of the study.)