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

Study Overview
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Brief Summary
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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.

Official Title
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Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Adolescent Idiopathic Scoliosis Patients and Neuromuscular Ambulators

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Device: Pedicle screws
* Device: Laminar Hooks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thoracic Pedicle Screws<br>Group treated with pedicle screws in the thoracic spine | Device: Pedicle screws<br>* Screws that are placed into the pedicle of vertebral body.<br>|
| Active Comparator: Laminar Hooks<br>Group treated with hooks in the thoracic spine | Device: Laminar Hooks<br>* Hooks are placed over the lamina of the vertebral body<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main Thoracic Cobb | X-rays measures the degree of curve in the thoracic spine. | 24 months post-operative | 
| Rotation | The degree to which the spinal column is rotated from its normal position will be assessed. | 24 months post-operative | 
| 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. | 24 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized, controlled, hooks, screws