An interventional study of Pedicle screws and Laminar Hooks in Adolescent Idiopathic Scoliosis, sponsored by University of Mississippi Medical Center. Completed at 1 site in United States. Open to participants aged 7 Years to 21 Years. Per ClinicalTrials.gov, last updated 2014-02-03.
Sponsored by University of Mississippi Medical Center · Not applicable, Interventional, and Treatment
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 58 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group treated with pedicle screws in the thoracic spine
Device: Pedicle screws
Group treated with hooks in the thoracic spine
Device: Laminar Hooks
Screws that are placed into the pedicle of vertebral body.
Hooks are placed over the lamina of the vertebral body
Main Thoracic Cobb
X-rays measures the degree of curve in the thoracic spine.
Time frame: 24 months post-operative
Rotation
The degree to which the spinal column is rotated from its normal position will be assessed.
Time frame: 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.
Time frame: 24 months post-operative
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
Patients with adolescent idiopathic scoliosis were recruited at a University Mississippi Medical center clinic from Nov. 2005 to Dec. 2008.
| Milestone | Thoracic Pedicle Screws | Laminar Hooks |
|---|---|---|
| Started | 29 | 29 |
| Completed | 19 | 18 |
| Not completed | 10 | 11 |
| Withdrew: Lost to follow-up | 4 | 6 |
| Withdrew: More than 2 hooks in thoracic | 3 | 0 |
| Withdrew: Neuromuscular | 2 | 1 |
| Withdrew: Not randomized | 1 | 2 |
| Withdrew: Lenke 6 classification | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 |
X-rays measures the degree of curve in the thoracic spine.
| Degree | Thoracic Pedicle Screws | Laminar Hooks |
|---|---|---|
| Preoperative | 55 ± 6 | 58 ± 8 |
| 4 weeks post-operative | 15 ± 7 | 18 ± 8 |
| 24 months at final follow-up | 14 ± 6 | 23 ± 8 |
The degree to which the spinal column is rotated from its normal position will be assessed.
| degree | Thoracic Pedicle Screws | Laminar Hooks |
|---|---|---|
| Preoperative | 15 ± 4 | 14 ± 4 |
| 24 month post-operative | 7 ± 3 | 11 ± 5 |
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.
| units on a scale | Thoracic Pedicle Screws | Laminar Hooks |
|---|---|---|
| Preoperative | 3.9 ± 0.2 | 3.9 ± 0.2 |
| 24 months post operative | 4.0 ± 0.2 | 4.1 ± 0.3 |
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.
| units on a scale | Thoracic Pedicle Screws | Laminar Hooks |
|---|---|---|
| Resting Pain Scale Preoperative | 2 ± 2.31 | 1.96 ± 2.49 |
| Resting Pain Scale 24 mo Post-operative | 1.25 ± 1.86 | 1.0 ± 1.41 |
| Mobilization Preoperative Pain Scale | 2.433 ± 2.74 | 2.16 ± 2.34 |
| Mobilization 24 mo Postoperative Pain Scale | 1.25 ± 2.17 | 1.6 ± 1.55 |
Collected over No adverse events occurred.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Thoracic Pedicle Screws | — | 0/29 (0%) | 0/29 (0%) |
| Laminar Hooks | — | 0/29 (0%) | 0/29 (0%) |
| Age, Categorical(Participants) | Thoracic Pedicle Screws | Laminar Hooks | Total |
|---|---|---|---|
| <=18 years | 28 | 27 | 55 |
| Between 18 and 65 years | 1 | 2 | 3 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Thoracic Pedicle Screws | Laminar Hooks | Total |
|---|---|---|---|
| Mean | 13.62 ± 2.21 | 14.17 ± 2.21 | 13.90 ± 2.21 |
| Sex: Female, Male(Participants) | Thoracic Pedicle Screws | Laminar Hooks | Total |
|---|---|---|---|
| Female | 25 | 22 | 47 |
| Male | 4 | 7 | 11 |
| Region of Enrollment(participants) | Thoracic Pedicle Screws | Laminar Hooks | Total |
|---|---|---|---|
| United States | 29 | 29 | 58 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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University of Mississippi Medical Center