Adolescent Idiopathic Scoliosis
Conditions
Keywords
randomized, controlled, hooks, screws
Brief summary
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.
Interventions
DEVICEPedicle screws
Screws that are placed into the pedicle of vertebral body.
DEVICELaminar Hooks
Hooks are placed over the lamina of the vertebral body
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main Thoracic Cobb | 24 months post-operative | X-rays measures the degree of curve in the thoracic spine. |
| Rotation | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobilization and Pain Survey | 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. |
Countries
United States
Participant flow
Recruitment details
Patients with adolescent idiopathic scoliosis were recruited at a University Mississippi Medical center clinic from Nov. 2005 to Dec. 2008.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Thoracic Pedicle Screws Group treated with pedicle screws in the thoracic spine | 29 |
| Laminar Hooks Group treated with hooks in the thoracic spine | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lenke 6 Classification | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 6 |
| Overall Study | More than 2 hooks in thoracic | 3 | 0 |
| Overall Study | Neuromuscular | 2 | 1 |
| Overall Study | Not Randomized | 1 | 2 |
Baseline characteristics
| Characteristic | Laminar Hooks | Thoracic Pedicle Screws | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 28 Participants | 55 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous | 14.17 years STANDARD_DEVIATION 2.21 | 13.62 years STANDARD_DEVIATION 2.21 | 13.90 years STANDARD_DEVIATION 2.21 |
| Region of Enrollment United States | 29 participants | 29 participants | 58 participants |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Main Thoracic Cobb
X-rays measures the degree of curve in the thoracic spine.
Time frame: 24 months post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thoracic Pedicle Screws | Main Thoracic Cobb | Preoperative | 55 Degree | Standard Deviation 6 |
| Thoracic Pedicle Screws | Main Thoracic Cobb | 4 weeks post-operative | 15 Degree | Standard Deviation 7 |
| Thoracic Pedicle Screws | Main Thoracic Cobb | 24 months at final follow-up | 14 Degree | Standard Deviation 6 |
| Laminar Hooks | Main Thoracic Cobb | Preoperative | 58 Degree | Standard Deviation 8 |
| Laminar Hooks | Main Thoracic Cobb | 4 weeks post-operative | 18 Degree | Standard Deviation 8 |
| Laminar Hooks | Main Thoracic Cobb | 24 months at final follow-up | 23 Degree | Standard Deviation 8 |
Primary
Rotation
The degree to which the spinal column is rotated from its normal position will be assessed.
Time frame: 24 months post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thoracic Pedicle Screws | Rotation | Preoperative | 15 degree | Standard Deviation 4 |
| Thoracic Pedicle Screws | Rotation | 24 month post-operative | 7 degree | Standard Deviation 3 |
| Laminar Hooks | Rotation | Preoperative | 14 degree | Standard Deviation 4 |
| Laminar Hooks | Rotation | 24 month post-operative | 11 degree | Standard Deviation 5 |
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.
Time frame: 24 months post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thoracic Pedicle Screws | Scoliosis Research Society-30 Survey | Preoperative | 3.9 units on a scale | Standard Deviation 0.2 |
| Thoracic Pedicle Screws | Scoliosis Research Society-30 Survey | 24 months post operative | 4.0 units on a scale | Standard Deviation 0.2 |
| Laminar Hooks | Scoliosis Research Society-30 Survey | Preoperative | 3.9 units on a scale | Standard Deviation 0.2 |
| Laminar Hooks | Scoliosis Research Society-30 Survey | 24 months post operative | 4.1 units on a scale | Standard Deviation 0.3 |
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.
Time frame: 24 months post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thoracic Pedicle Screws | Mobilization and Pain Survey | Resting Pain Scale Preoperative | 2 units on a scale | Standard Deviation 2.31 |
| Thoracic Pedicle Screws | Mobilization and Pain Survey | Resting Pain Scale 24 mo Post-operative | 1.25 units on a scale | Standard Deviation 1.86 |
| Thoracic Pedicle Screws | Mobilization and Pain Survey | Mobilization Preoperative Pain Scale | 2.433 units on a scale | Standard Deviation 2.74 |
| Thoracic Pedicle Screws | Mobilization and Pain Survey | Mobilization 24 mo Postoperative Pain Scale | 1.25 units on a scale | Standard Deviation 2.17 |
| Laminar Hooks | Mobilization and Pain Survey | Mobilization 24 mo Postoperative Pain Scale | 1.6 units on a scale | Standard Deviation 1.55 |
| Laminar Hooks | Mobilization and Pain Survey | Resting Pain Scale Preoperative | 1.96 units on a scale | Standard Deviation 2.49 |
| Laminar Hooks | Mobilization and Pain Survey | Mobilization Preoperative Pain Scale | 2.16 units on a scale | Standard Deviation 2.34 |
| Laminar Hooks | Mobilization and Pain Survey | Resting Pain Scale 24 mo Post-operative | 1.0 units on a scale | Standard Deviation 1.41 |