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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: Completed NA study, sponsored by University of Mississippi Medical Center.

NCT01581021 is a NA study that has completed, run by University of Mississippi Medical Center. The registered enrollment target is 58 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

X-rays measures the degree of curve in the thoracic spine.

Interventions

  • DEVICE Pedicle screws
  • DEVICE Laminar Hooks

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2005-08
Est. Completion 2011-08
Phase NA

What the finished NCT01581021 record still lists

NCT01581021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Pedicle screws is the first listed.

NCT01581021 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01581021's enrollment target sits among peer trials

58 1256th of 2000 higher than 740 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01581021, the US trial registry maintained by the National Library of Medicine. NCT01581021 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.