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

NCT01581021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-02-03

Study results available
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Summary

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.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

DEVICE

Pedicle screws

Screws that are placed into the pedicle of vertebral body.

DEVICE

Laminar Hooks

Hooks are placed over the lamina of the vertebral body

Sponsors & Collaborators

  • University of Mississippi Medical Center

    lead OTHER

Principal Investigators

  • Lawrence L Haber, MD · University of Mississippi Medical Center

  • Erika D Womack, BS MS · University of Mississippi Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01581021 on ClinicalTrials.gov