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临床试验/NCT07609758
NCT07609758Enrolling By Invitation不适用

Pediatric Acetabular Fracture Registry: Long-Term Follow-Up and Outcomes

University of Utah1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年4月9日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
120
试验地点
1

研究概览

简要总结

The investigators primary objective is to determine the fracture patterns, displacement-based treatment decisions, immediate and long-term complications, clinical, radiographic and patient reported outcomes of acetabular fractures with open physes.

Hypothesis: This study will demonstrate that more complex and displaced fracture patterns are associated with a greater incidence of complications and poorer outcomes.

The investigators secondary objective is to create a pediatric acetabular registry that can be used to track fracture patterns, displacement-based treatment decisions, immediate and long-term complications, clinical, radiographic and patient reported outcomes of acetabular fractures with open physes.

Hypothesis: This study will demonstrate that more complex and displaced fracture patterns are associated with a greater incidence of complications and poorer outcomes.

详细描述

Introduction

This document is a protocol for a human research study. This two-phased study will be carried out in accordance with the applicable United States government regulations and the University of Utah and Primary Children's Hospital research policies and procedures. The first phase will consist of a retrospective cohort that will be contacted for follow-up data, while the second phase will consist of the creation of a prospective database.

Background and Current Clinical Data

Pelvic fractures, consisting of the pelvic ring and acetabulum, represent less than 0.2% of all pediatric fractures. Isolated acetabular fractures are estimated to represent 9.8% of pelvic fractures, while combined pelvic ring and acetabular fractures are estimated at 20%. Notably, these injuries occur as a result of high-energy trauma, most commonly during motor vehicle-related accidents.Despite the high-energy forces involved, pediatric patients are less likely to experience fracture-induced hemodynamic instability. This is due to factors such as limited displacement of fractures secondary to pelvis malleability, pelvic ligamentous strength, thickness of the pediatric periosteum and increased responsiveness of the pediatric hemostatic system. Consequently, the patient's life is more likely to be threatened by associated cranial, abdominal, thoracic, and neurological injuries, which occur in more than 60% of cases. Overall mortality rates are estimated between 3.2% to 18%. Acetabular fractures can also occur secondary to lower-energy mechanisms, such as hip dislocations during sports activity. The rarity of pediatric acetabulum fractures has resulted in limited high-quality data regarding clinical and patient reported outcomes (PRO), but the severity of these injuries indicates further observations are necessary.

The outcomes for pediatric acetabulum fractures are reported by a few small studies. Non- surgical and surgical management has resulted in acceptable clinical and radiographic outcomes. Past investigators have reported zero nonunions, one unplanned reoperation, and full return to activity in 18 patients. However, the study is limited by a small cohort and follow-up only to one year, which restricts the ability to observe the development of long-term complications such as arthritis or dysplasia. Other investigators have reported on 21 acetabulum fracture ORIF patients younger than 18 from 2001-2018, displaying favorable functional outcomes. However, only five patients had open physes, which severely limits the findings of the study to skeletally mature adolescents. Similar to adult acetabulum fractures, pediatric patients have a risk of post-traumatic osteoarthritis (PTOA). Additional complications of concern in skeletally immature patients are leg length inequality, hip dysplasia, and hip subluxation. These are secondary to a growth disturbance of the triradiate cartilage, which occurs due to osseous bridging across the cartilage or ossification of a physeal hematoma after injury. Growth disturbance has been reported in 14% of acetabulum fractures, while hip dysplasia has been estimated at 5%. However, the strength of both findings are limited by small sample sizes. Hip subluxation and dislocation are also associated with development of avascular necrosis (AVN) of the femoral head, osteonecrosis of the posterior acetabular wall, and sciatic nerve palsy. Hip reduction within 6 hours is associated with lower rates of AVN due to preservation of femoral head blood flow. While pediatric acetabulum fractures are associated with good outcomes, they are also associated with many potential complications that have lasting consequences for the patient. These outcomes will be best observed through long-term studies of the pediatric population.

研究设计

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

入排标准

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

入选标准

  • Patients aged 18 years or less (at time of injury) with open physes sustaining an acetabular fracture with primary treatment occurring at either University of Utah Hospital or Primary Children's Hospital from 2000-present.
  • Informed consent can be obtained from parent, guardian, or family member.

排除标准

  • History of metabolic or genetic bone disease (Ricket's, Osteogenesis Imperfecta),
  • pathologic fracture,
  • non-ambulatory prior to injury, paraplegic,
  • hemiplegic, or cognitive impairment that inhibits the participant's ability to answer patient reported outcome surveys.
  • Pregnancy

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Rothberg

Principle Investigator

University of Utah

研究点 (1)

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