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临床试验/NCT06429267
NCT06429267招募中不适用

Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications

Louisiana State University Health Sciences Center in New Orleans2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys

研究概览

简要总结

This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.

详细描述

This study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. The research will be conducted within the pediatric orthopedic department at CHNOLA, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. The primary objective of this study is to assess and compare the effectiveness of conventional metal screws and bioabsorbable screws in bone healing. This study aims to determine whether bioabsorbable screws are significantly superior to conventional titanium screws. The investigators hypothesize bioabsorbable screws are significantly noninferior to conventional metal screws in terms of complications based on prior surgical constructs that demonstrate bioabsorbable screws eliminate the need for a second surgery After informed consent has been obtained from the parents of patients, eligible patients undergoing cannulated screw fixation will be randomized into two groups: one group who will receive bioabsorbable screws and the other group who will receive metal screws (titanium or stainless steel).

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)

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

  • Primary fractures requiring fixation with cannulated screws

排除标准

  • Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis)
  • Secondary fractures
  • Non-union fractures
  • Tibial tubercle osteotomies (TTOs)
  • Slipped capital femoral epiphysis (SCFEs)
  • Unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age
  • Allergies or contraindications to screw materials

结局指标

主要结局

Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys

时间窗: 6 weeks, 6 months, 1 year

Pain, Upper Extremity and Mobility. These questionnaires are scored using T scores. For pain, a higher score is a worse outcome. For mobility and upper extremity, a lower score is a worse outcome. Min value is 0 and max is 100 for all.

次要结局

  • Complications(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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