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临床试验/NCT01581021
NCT01581021已完成不适用

Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Adolescent Idiopathic Scoliosis Patients and Neuromuscular Ambulators

University of Mississippi Medical Center1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2005年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Main Thoracic Cobb

研究概览

简要总结

Scoliosis is a deformity in which there is an abnormal curvature of the spine. Surgery is the main method of correcting this deformity. Rods are attached to the spine to make it strait. There are two ways to fix these rods to the bone of the spine: laminar hooks or pedicle screws. Hooks are an older form of fixation and do not penetrate the bone, but are instead placed over a part of the vertebra called the lamina. Screws are newer and do penetrate the bone. Screws are placed into the part of the vertebra called the pedicle. Most surgeons think screws correct scoliosis better than hooks. The current literature agrees that screws are better for deformity correction in the lumbar spine and patients with severe deformity. There is disagreement in the literature regarding which works better in the thoracic spine in less severe deformity. There are no randomized, controlled trials in the literature that examine whether constructs that use hooks in the thoracic spine and screws in the lumbar spine (called hybrid constructs) work as well as all-screw constructs. This clinical study is a randomized controlled trial being conducted to evaluate treatment outcomes in patients with scoliosis undergoing surgical correction for their curves using either all-screw or hybrid constructs as fixation devices. The study population is limited to those with less severe deformity and the investigators' hypothesis is that hybrid constructs will be as acceptable as screws in terms of correction.

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, Investigator)

入排标准

年龄范围
7 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Primary diagnosis of adolescent idiopathic scoliosis or neuromuscular scoliosis
  • •Fusion to include six of more levels in thoracic, thoracolumbar, or lumbar region
  • •Less than 21 years of age
  • •Able to undergo surgery based on physical exam, medical history, and surgeon judgement
  • •Willing to comply with the follow-up clinical and radiographic evaluation schedules
  • •Informed consent signed by patient and parent or legal guardian

排除标准

  • •Scoliosis with curvature greater than 100 degrees or less than 40
  • •Smaller juvenile subjects weighing less than 30 kg
  • •Rigid curves
  • •Infection in the disc or spine, past or present
  • •Subject is pregnant
  • •Evidence of abuse of alcohol and/or illicit drugs
  • •Subject is prisoner
  • •Subject has evidence of tumor(s), malignant disease or other significant illness with decreased life expectancy
  • •Subject is immunocompromised or being treated with immunosuppressive agents

研究组 & 干预措施

Thoracic Pedicle Screws

Active Comparator

Group treated with pedicle screws in the thoracic spine

干预措施: Pedicle screws (Device)

Laminar Hooks

Active Comparator

Group treated with hooks in the thoracic spine

干预措施: Laminar Hooks (Device)

结局指标

主要结局

Main Thoracic Cobb

时间窗: 24 months post-operative

X-rays measures the degree of curve in the thoracic spine.

Rotation

时间窗: 24 months post-operative

The degree to which the spinal column is rotated from its normal position will be assessed.

Scoliosis Research Society-30 Survey

时间窗: 24 months post-operative

Participants were administered a validated survey for evaluating patient quality of life and satisfaction with treatment. Total SRS-30 scores (max = 150) and the domains: function (max = 35), pain (max = 30), self-image (max = 45), mental health (max = 25), and satisfaction with management (max = 15) were analyzed on a scale from 1 (worst) to 5 (best). The mean was obtained by dividing maximum possible score by the number of questions answered.

次要结局

  • Mobilization and Pain Survey(24 months post-operative)

研究者

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

Lawrence Haber

Chief Pediatric Orthopaedics/Associate Professor

University of Mississippi Medical Center

研究点 (1)

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