Pre-market Clinical Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fracture Healing
研究概览
简要总结
Single-centre, randomised, controlled, non-profit study on a custom-made medical device for immobilisation of radius and ulna fracture in paediatric patients.
The aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3D-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. The patients will be randomised between use of customised 3D- printed wrist immobilisisation device and plaster.
详细描述
The device under investigation has already been the subject of a pilot study (clinical investigation code: T3DDY01) with significant result. These results are also preparatory to the proposed new investigation, which aims to extend its applicability to more complex clinical conditions. Compared to the previous one, the new study will be able to take advantage of an improved acquisition process of the anatomy of the child's upper limb, obtained by updating the model of the chambers used.
The aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3D-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. The patients will be randomised between use of customised 3D- printed wrist immobilisisation device and plaster.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 7 and 13 years with compound fracture of the distal metaphysis of radius and/or ulna at "green wood" and initial angulation <20°;
- •Informed consent obtained.
排除标准
- •Complete fracture of radius and ulna;
- •Open fracture of radius and ulna;
- •Polytrauma, polyfracture;
- •Presence of neurovascular deficit at presentation;
- •Presence of underlying bone disease;
- •Presence of acute or chronic skin disorders;
- •Psycho-behavioural disorders;
- •Presence of ≥1 skin lesions according to NPUAP/EPUAP classification;
- •Specific allergies related to the materials used in the tested device;
- •Inability to perform follow-up examinations.
研究组 & 干预措施
T3DDY01
Acquired a digital acquisition of the patient's forearm using the Intel RealSense D415. The arm of the patient' is placed on a support to allow the plaster nurse to position of the wrist at the correct angle to treat the fracture. The limb is temporarily immobilised in a plaster cast by the nurses of the practice. The patient is booked for a subsequent outpatient visit (which will be conducted within 72 hours of digital acquisition of the forearm) for the application of the device under investigation. The production of the device through a Stratasys F370 3D printer owned by the Meyer Children's Hospital IRCCS. The material used is ABS (Acrylonitrile butadiene styrene) supplied by Stratasys and specific to the machine. Placement of the device on the patient by the investigating nurses, after removal of the temporary device. Collection of data on the evaluation of study parameters.
干预措施: T3DDY01 (Device)
PLASTER
Traditional device placement (antibrachio-metacarpal cast). Radiological check at 7 days after trauma to verify the angle of the stumps fracture angle, followed by radiological check at 14 days if necessary . Removal of the plaster cast 30 days after the trauma, radiological check to verify the formation of bone callus, clinical evaluation and data collection at the end of treatment
干预措施: PLASTER (Device)
结局指标
主要结局
Fracture Healing
时间窗: At 7 and 30 day from the use of the device
Completion of the therapeutic course, i.e. fracture healing without intervention following immobilisation device placement with residual angulation \< 20°. Radiographic assessment of the fracture angle at 7 and 30 days after application of the device application; * Radiographic assessment of fracture healing at 30 days, defined as presence of bone callus on 3 out of 4 fracture margins; * If at the 7-day assessment the fracture angle appears critical, defined as \>15° or an increase \>5° from the initial radiograph, the patient will undergo a further radiographic assessment after a further 7 days (i.e. 14 days from the start of treatment). * Functional recovery of the limb will be investigated with a clinical examination 30 days after removal of the device (60 from the start of treatment), where arc of motion and elective pain and painability to active mobilisation, as per normal clinical practice.
次要结局
- Adverse event(through study completetion, an average of 1 year)
- Pain evaluation(During the study (7, 30-day and FU))
- Presence of skin lesions or other manifestations of intolerance to the device(During the tudy (at 30 days))
- Acceptance of the device(At 7 and 30 days from the use of the device)
- Comfort of use of devices(During the study (at 7 and 30 days from the use of the device))
- Structural analysis of devices(30 days After the start of the treatment)
- Usability for design purposes of the controlate(Through study completion, an average of 1 year)
研究者
Alessandro Zanardi
Principal Investigator
Meyer Children's Hospital IRCCS