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NCT01581021 · ClinicalTrials.gov registry record · NA
Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis
A NA study, sponsored by University of Mississippi Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
NCT01581021 is a NA study that has completed, run by University of Mississippi Medical Center. The registered enrollment target is 58 participants.
The verdict
NCT01581021, a NA study, has completed, sponsored by University of Mississippi Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
Study 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
- DEVICE Pedicle screws
- DEVICE Laminar Hooks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2005-08 |
| Est. Completion | 2011-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01581021
The ClinicalTrials.gov registry entry for NCT01581021 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Mississippi Medical Center, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pedicle screws is the first listed.
NCT01581021 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01581021 about?
NCT01581021 is a clinical study titled "Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis". 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...
What is the current status of trial NCT01581021?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2005-08. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01581021?
The interventions under investigation include: Pedicle screws (DEVICE), Laminar Hooks (DEVICE).
Who is sponsoring clinical trial NCT01581021?
This trial is sponsored by University of Mississippi Medical Center, which has 96 total clinical trials registered on ClinicalTrials.gov.
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