Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis
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.
|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|
- 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.
- 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.
|Study Start Date:||August 2005|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581021
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39202|
|Principal Investigator:||Lawrence L Haber, MD||University of Mississippi Medical Center|
|Study Director:||Erika D Womack, BS MS||University of Mississippi Medical Center|