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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pedicle screws
Laminar Hooks
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring randomized, controlled, hooks, screws

Eligibility Criteria

7 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Thoracic Pedicle Screws

Laminar Hooks

Arm Description

Group treated with pedicle screws in the thoracic spine

Group treated with hooks in the thoracic spine

Outcomes

Primary Outcome Measures

Main Thoracic Cobb
X-rays measures the degree of curve in the thoracic spine.
Rotation
The degree to which the spinal column is rotated from its normal position will be assessed.
Scoliosis Research Society-30 Survey
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
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.

Full Information

First Posted
April 13, 2012
Last Updated
December 13, 2013
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01581021
Brief Title
Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis
Official Title
Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Adolescent Idiopathic Scoliosis Patients and Neuromuscular Ambulators
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
randomized, controlled, hooks, screws

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic Pedicle Screws
Arm Type
Active Comparator
Arm Description
Group treated with pedicle screws in the thoracic spine
Arm Title
Laminar Hooks
Arm Type
Active Comparator
Arm Description
Group treated with hooks in the thoracic spine
Intervention Type
Device
Intervention Name(s)
Pedicle screws
Intervention Description
Screws that are placed into the pedicle of vertebral body.
Intervention Type
Device
Intervention Name(s)
Laminar Hooks
Intervention Description
Hooks are placed over the lamina of the vertebral body
Primary Outcome Measure Information:
Title
Main Thoracic Cobb
Description
X-rays measures the degree of curve in the thoracic spine.
Time Frame
24 months post-operative
Title
Rotation
Description
The degree to which the spinal column is rotated from its normal position will be assessed.
Time Frame
24 months post-operative
Title
Scoliosis Research Society-30 Survey
Description
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.
Time Frame
24 months post-operative
Secondary Outcome Measure Information:
Title
Mobilization and Pain Survey
Description
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.
Time Frame
24 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence L Haber, MD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erika D Womack, BS MS
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States

12. IPD Sharing Statement

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

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