Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis
|ClinicalTrials.gov Identifier: NCT01581021|
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : February 3, 2014
Last Update Posted : February 3, 2014
|Condition or disease||Intervention/treatment|
|Adolescent Idiopathic Scoliosis||Device: Pedicle screws Device: Laminar Hooks|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Adolescent Idiopathic Scoliosis Patients and Neuromuscular Ambulators|
|Study Start Date :||August 2005|
|Primary Completion Date :||August 2011|
|Study Completion Date :||August 2011|
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
- Main Thoracic Cobb [ Time Frame: 24 months post-operative ]X-rays measures the degree of curve in the thoracic spine.
- Rotation [ Time Frame: 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 [ Time Frame: 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.
- Mobilization and Pain Survey [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|