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Completed

NCT Number: NCT01581021

Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pedicle screws

Device

Screws that are placed into the pedicle of vertebral body.

Laminar Hooks

Device

Hooks are placed over the lamina of the vertebral body

Primary outcomes

  1. Main Thoracic Cobb

    Time frame: 24 months post-operative

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

  2. Rotation

    Time frame: 24 months post-operative

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

  3. Scoliosis Research Society-30 Survey

    Time frame: 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.

Secondary outcomes

  1. Mobilization and Pain Survey

    Time frame: 24 months post-operative

    Using a numeric rating scale (0 = no pain and 10 = unbearable pain), patients were asked to estimate their experienced pain while at rest and when mobile by specifying a number on the scale.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Apr 19, 2012
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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