跳至主要内容
临床试验/NCT04207892
NCT04207892进行中(未招募)不适用

PedORTHO-A Prospective Multicenter Observational Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children

AO Innovation Translation Center17 个研究点 分布在 12 个国家目标入组 1,000 人开始时间: 2022年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,000
试验地点
17
主要终点
Data collection of fracture and trauma details

研究概览

简要总结

International registry to collect prospective treatment and outcomes data on specific, key non-pathological fractures in children with open physes. Data will be collected during follow-up visits according to standard of care at 3 to 8 weeks, 3, 6, 12 and 24 months

详细描述

This international registry will collect prospective treatment and outcomes data on specific, key non-pathological fractures in children with open physes. The long-term goal is to build this registry to include all fractures according to the AO pediatric fracture classification (AO PCCF). However, to establish proof-of-principle and study feasibility, the investigators aim to first begin with the inclusion of a limited number of key long bone fracture types for which optimal treatment and management are under particular debate, or for which substantial clinical equipoise exists. Consequently, the investigators aim to begin with separate registry arms based on defined fracture segments in specific bones. Each registry arm will be defined by a customized set of outcomes to be collected. Participants will be enrolled into these specific arms according to their injury diagnosis. The registry arms will be categorized as follows:

  • Proximal humerus fractures
  • Distal humerus fractures
  • Proximal radius fractures
  • Forearm shaft fractures
  • Tibial shaft fractures (with/without fibula fracture)

All participants enrolled in the registry will be followed over the course of their treatment from the time of enrolment to end of treatment in accordance with the treating surgeon's regular clinical practice. All relevant information will be recorded at baseline and at each follow-up visit that participants attend at the orthopedic clinic, according to standard of care for each fracture type. A standardized set of prospective data including demographic information, baseline injury information, diagnosis, treatment details and clinical, radiographic, functional, and PROs will be collected for each participant. Data involving additional outcomes or variables may also be collected depending on the specific sub-study or registry arm that the participant is enrolled in.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Radiologically confirmed open physis in the injured bone at time of injury
  • Diagnosis of an isolated fracture according to the AO PCCF
  • Willingness and ability of the patient/parents/legally responsible care giver to participate in the registry, including obtaining imaging and adhering to follow-up procedures according to standard of care in each clinic
  • Willingness and ability of the parent(s) to support the patient in his/her study participation
  • Ability of parents or a legal guardian to understand the content of the patient information/ICF and to sign and date the IRB/EC approved written informed consent form

排除标准

  • Radiologically confirmed closed physis in the injured bone at time of injury
  • Polytrauma/multiple fractures
  • Previous fracture of the same anatomical region
  • Underlying musculoskeletal or neuromuscular disorder
  • Present to participating centers with a displaced humeral fracture, tibial shaft fracture, forearm fracture, or femoral neck fracture at greater than 4 weeks postinjury
  • Unable to provide the legal consent
  • Inability of the patient/parents/legally responsible caregiver to participate in imaging and/or FU procedures

结局指标

主要结局

Data collection of fracture and trauma details

时间窗: up to 24 months

To analyze the AO Pediatric Long Bone Fracture Classification in terms of utility for treatment decision-making and prediction of fracture outcomes

次要结局

  • Axial deviation and range of motion (ROM)(up to 24 months)
  • Patient-reported outcome(up to 24 months)
  • Leg length discrepancy(up to 24 months)
  • Return to full activity(up to 24 months)
  • Implant removal(up to 24 months)

研究者

发起方
AO Innovation Translation Center
申办方类型
Other
责任方
Sponsor

研究点 (17)

Loading locations...

相似试验

Registry of Pediatric Orthopedic Trauma and Health... | 临床试验