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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lawrence Haber, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01581021
First received: April 13, 2012
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Adolescent Idiopathic Scoliosis
Device: Pedicle screws
Device: Laminar Hooks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Adolescent Idiopathic Scoliosis Patients and Neuromuscular Ambulators

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Main Thoracic Cobb [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]
    X-rays measures the degree of curve in the thoracic spine.

  • Rotation [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]
    The degree to which the spinal column is rotated from its normal position will be assessed.

  • Scoliosis Research Society-30 Survey [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Mobilization and Pain Survey [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]
    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.


Enrollment: 58
Study Start Date: August 2005
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thoracic Pedicle Screws
Group treated with pedicle screws in the thoracic spine
Device: Pedicle screws
Screws that are placed into the pedicle of vertebral body.
Active Comparator: Laminar Hooks
Group treated with hooks in the thoracic spine
Device: Laminar Hooks
Hooks are placed over the lamina of the vertebral body

  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581021

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39202
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Lawrence L Haber, MD University of Mississippi Medical Center
Study Director: Erika D Womack, BS MS University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: Lawrence Haber, Chief Pediatric Orthopaedics/Associate Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01581021     History of Changes
Other Study ID Numbers: 2005-0110
Study First Received: April 13, 2012
Results First Received: April 14, 2013
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
randomized
controlled
hooks
screws

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014