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

Not Applicable

Completed

Conditions: Adolescent Idiopathic Scoliosis

Interventions: Device: Pedicle screws
Device: Laminar Hooks

Registration Number: NCT01581021

Lead Sponsor: University of Mississippi Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic Pedicle Screws	Pedicle screws	Group treated with pedicle screws in the thoracic spine
Laminar Hooks	Laminar Hooks	Group treated with hooks in the thoracic spine

Primary Outcome Measures

Name	Time	Method
Main Thoracic Cobb	24 months post-operative	X-rays measures the degree of curve in the thoracic spine.
Rotation	24 months post-operative	The degree to which the spinal column is rotated from its normal position will be assessed.
Scoliosis Research Society-30 Survey	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 Outcome Measures

Name	Time	Method
Mobilization and Pain Survey	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.