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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic Pedicle Screws | Active Comparator | Group treated with pedicle screws in the thoracic spine |
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| Laminar Hooks | Active Comparator | Group treated with hooks in the thoracic spine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedicle screws | Device | Screws that are placed into the pedicle of vertebral body. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence L Haber, MD | University of Mississippi Medical Center | Principal Investigator |
| Erika D Womack, BS MS | University of Mississippi Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39202 | United States |
After consent, the patient was given an identification number with the computer-generated randomized construct assignment. Enrolled participants might have been excluded from the study due to not being randomized.
Patients with adolescent idiopathic scoliosis were recruited at a University Mississippi Medical center clinic from Nov. 2005 to Dec. 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Thoracic Pedicle Screws | Group treated with pedicle screws in the thoracic spine |
| FG001 | Laminar Hooks | Group treated with hooks in the thoracic spine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Thoracic Pedicle Screws | Group treated with pedicle screws in the thoracic spine |
| BG001 | Laminar Hooks | Group treated with hooks in the thoracic spine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Main Thoracic Cobb | X-rays measures the degree of curve in the thoracic spine. | Posted | Mean | Standard Deviation | Degree | 24 months post-operative |
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No adverse events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thoracic Pedicle Screws | Group treated with pedicle screws in the thoracic spine |
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The design of this study is a computer-generated randomized trial. Initially, the first 3 participants were not computer-randomized and therefore, these subjects had to be removed from the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lawrence Haber | University of Mississippi Medical Center | 601-984-6525 | lhaber@umc.edu |
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| ID | Term |
|---|---|
| D065289 | Pedicle Screws |
| ID | Term |
|---|---|
| D001863 | Bone Screws |
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Laminar Hooks | Device | Hooks are placed over the lamina of the vertebral body |
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| Neuromuscular |
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| Not Randomized |
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| Lenke 6 Classification |
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| Lack of Efficacy |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Primary | Rotation | The degree to which the spinal column is rotated from its normal position will be assessed. | Posted | Mean | Standard Deviation | degree | 24 months post-operative |
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|
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| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months post-operative |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months post-operative |
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| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Laminar Hooks | Group treated with hooks in the thoracic spine | 0 | 29 | 0 | 29 |
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| D009984 |
| Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |
| Mobilization Preoperative Pain Scale |
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| Mobilization 24 mo Postoperative Pain Scale |
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