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临床试验/NCT02772770
NCT02772770进行中(未招募)不适用

Pediatric ACL: Understanding Treatment Options (PLUTO)

Boston Children's Hospital10 个研究点 分布在 1 个国家目标入组 765 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
765
试验地点
10
主要终点
Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC)

研究概览

简要总结

Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients.

详细描述

Anterior Cruciate Ligament (ACL) injuries are being seen with increased frequency in pediatric and adolescent patients. The management of these injuries is controversial and includes nonoperative treatment and operative treatment with various surgical techniques. Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients. Accrual will take place over eight years at 9 pediatric sports medicine centers. Post-treatment outcome assessment will be performed at 6-9 months, 1 year, and 2, 5, and 10 years after treatment , including functional outcome, activity level, health-related quality of life, graft survivorship, knee stability, knee motion, and growth disturbance.

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
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of complete intrasubstance ACL tear
  • Skeletally Immature (by knee radiographs)

排除标准

  • Prior ACL surgery on the ipsilateral knee
  • Congenital ACL deficiency
  • Multiple ligament reconstruction required
  • Other significant comorbidities including syndromic conditions, neuromuscular disorders or developmental delay
  • If scheduling of the ACL surgery is impacted by the skeletal maturity of the patient
  • Simultaneous bilateral ACL tears

结局指标

主要结局

Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC)

时间窗: 2 years

To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique.

次要结局

  • Graft failure (MRI, Lachman, Pivot-Shift)(2 years)
  • Activity level (P-FABS and Physical Activity Questionnaire)(2 years)
  • Health-related quality of life (Pediatric Quality of Life Inventory (PedsQL)(2 years)
  • Growth disturbance (angular deformity, leg length discrepancy per clinical exam and radiographs)(2 years)

研究者

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

Mininder Kocher

Principal Investigator

Boston Children's Hospital

研究点 (10)

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