Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis
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|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||Phase|
|Adolescent Idiopathic Scoliosis||Device: Pedicle screws Device: Laminar Hooks||Not Applicable|
|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|
|Actual Primary Completion Date :||August 2011|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|