NCT03506334Enrolling By Invitation不适用
Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Revision spine surgery within 2 years of index procedure
研究概览
简要总结
The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male & female, age 10 years to 16 years.
- •Scoliosis curve between 40-70 degrees.
- •At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.
- •Adolescent idiopathic scoliosis.
- •Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar).
- •Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate.
- •Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits.
排除标准
- •Congenital, neuromuscular or syndromic scoliosis.
- •Underlying neuromuscular disease.
- •Nonflexible curves (bending films show residual curve greater than 40 degrees).
- •Prior surgery for scoliosis treatment.
- •Patients with active systemic infection.
- •Known, reported allergies to titanium, PET, or PCU. Known, reported substance abuse, including alcohol.
研究组 & 干预措施
Pediatric Scoliosis Patients
Experimental
Tether group
干预措施: AVBT using Dynesys System Components (Device)
Pediatric Scoliosis Control Patients
Active Comparator
Fusion (control) group
干预措施: Spine fusion (Procedure)
结局指标
主要结局
Revision spine surgery within 2 years of index procedure
时间窗: 2 years
yes/no parameter, was revision surgery performed within 2 years of index procedure
次要结局
- Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)(1 year)
- Spinal disc health utilizing MRI(At least 1 year postoperatively)
- Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm)(1 year)
- Curve flexibility over instrumented vertebra > 5 degrees(At least 1 year postoperatively)
研究者
A. Noelle Larson, MD
Principal Investigator
Mayo Clinic
研究点 (1)
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