Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis - Full Text View

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 (AIS)	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 AIS (Adolescent Idiopathic Scoliosis) Patients and Neuromuscular Ambulators

Resource links provided by NLM:

MedlinePlus related topics: Scoliosis

U.S. FDA Resources

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

Primary Outcome Measures:

Sagittal and Coronal X-rays [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
X-rays will be used to measure the degree of curve in the spine.
Rotation [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
The degree to which the spinal column is rotated from it's normal position will be assessed.
SRS (Scoliosis Research Society)-30 Survey [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
Participants are administered a validated survey for evaluating patient quality of life and satisfaction with treatment.

Secondary Outcome Measures:

Mobilization and pain survey [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
Patients are given a scale that measure their mobility and pain.

Enrollment:	57
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 AIS 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

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 Womack, BA 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
Last Updated:	February 23, 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 May 22, 2013