Adolescent Idiopathic ScoliosisNCT01581021
Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis
A study testing Pedicle screws and Laminar Hooks in people with Adolescent Idiopathic Scoliosis, run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Pedicle screws and Laminar Hooks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39202
About this study
Official title: Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Adolescent Idiopathic Scoliosis Patients and Neuromuscular Ambulators
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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Pedicle screws, Laminar Hooks
- Keywords
- randomized, controlled, hooks, screws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedicle screwsDevice
Screws that are placed into the pedicle of vertebral body.
Laminar HooksDevice
Hooks are placed over the lamina of the vertebral body
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Pedicle Screws | Active comparator | Group treated with pedicle screws in the thoracic spine Receives: Device: Pedicle screws |
| Laminar Hooks | Active comparator | Group treated with hooks in the thoracic spine Receives: Device: Laminar Hooks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Thoracic Cobb
X-rays measures the degree of curve in the thoracic spine.
Measured: 24 months post-operative
Rotation
The degree to which the spinal column is rotated from its normal position will be assessed.
Measured: 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.
Measured: 24 months post-operative
Secondary outcomes (1)
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.
Measured: 24 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startAug 2005
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Haber, University of Mississippi Medical Center
- Investigators
- Lawrence L Haber, MD, Principal investigator, University of Mississippi Medical CenterErika D Womack, BS MS, Study director, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581021
- Sponsor's protocol ID
- 2005-0110
- Status last verified
- Dec 2013
- First submitted
- 13 Apr 2012
- Last updated
- 3 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Adolescent Idiopathic Scoliosis Patients and Neuromuscular Ambulators
- ClinicalTrials.gov ID
- NCT01581021
- Acronym / sponsor ID
- 2005-0110
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- randomized, controlled, hooks, screws
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Posted 3 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Pedicle Screws | Active comparator | Device: Pedicle screwsGroup treated with pedicle screws in the thoracic spine |
| Laminar Hooks | Active comparator | Device: Laminar HooksGroup treated with hooks in the thoracic spine |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedicle screwsScrews that are placed into the pedicle of vertebral body. | Device | Thoracic Pedicle Screws |
| Laminar HooksHooks are placed over the lamina of the vertebral body | Device | Laminar Hooks |
Primary outcome
Main Thoracic Cobb
Time frame: 24 months post-operative
X-rays measures the degree of curve in the thoracic spine.
Rotation
Time frame: 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
Time frame: 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.
1 secondary outcome
Mobilization and Pain Survey
Time frame: 24 months post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence L Haber, MD principal investigator
University of Mississippi Medical Center
Erika D Womack, BS MS study director
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedicle screws and Laminar Hooks in people with Adolescent Idiopathic Scoliosis, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Thoracic Cobb (time frame: 24 months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.