ScoliosisPhase 4NCT00510575
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
A Phase 4 study testing Spinal rod in people with Scoliosis, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
There are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no scientific evidence supporting the superiority of one size rod relative to the other. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Spinal rod
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Juvenile or Adolescent Idiopathic Scoliosis
- Anticipated spinal fusion surgery
Who cannot join
- Individuals younger than 11 years and older than 18 years
- Individuals with scoliosis carrying additional diagnoses of illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children - Los Angeles
Los Angeles, California, 90020
About this study
There are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no scientific evidence supporting the superiority of one size rod relative to the other. This study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.
Read the detailed description
For the correction of Juvenile and Adolescent idiopathic scoliosis, companies offer and surgeons use varying rod sizes not based on scientific evidence, but because of personal preference, availability and company loyalty. To date there has been no literature evaluating the benefit or harm of one rod size versus the other. Our dual-arm prospective study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm stainless steel instrumentation rods. These are both standard rods used in the community for this particular procedure, thus no additional risk exists for the patient. The results of this study will help guide surgeons in their decision making process when faced with the multitude of options offered by implant manufactures.
Comparison(s): 5.5mm stainless steel spinal rod versus 6.35mm stainless steel spinal rod for correction of juvenile and idiopathic scoliosis curves.
- Conditions
- Scoliosis
- Being tested
- Spinal rod
- Keywords
- Juvenile Scoliosis, Adolescent Scoliosis, Scoliosis Management, Spinal Fusion, Scoliosis instrumentation, Juvenile or Adolescent Idiopathic Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal rodDevice
Posterior spinal fusion using a 5.5 or 6.35 size rod
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects in this arm will receive the 5.5mm stainless steel instrumentation rod. Receives: Device: Spinal rod |
| 2 | Active comparator | Subjects in this arm will receive a 6.35mm stainless steel instrumentation rod. Receives: Device: Spinal rod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic measurements of curve angles and balance.
Measured: Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
Secondary outcomes (1)
Scoliosis Research Society-30 (SRS-30) questionnaire
Measured: Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terri Green, Shriners Hospitals for Children
- Investigators
- Norman Otsuka, MD, Study director, Shriners Hospitals for Children - Los AngelesRichard Bowen, MD, Principal investigator, Shriners Hospitals for Children - Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510575
- Sponsor's protocol ID
- SHCLA-0123
- Status last verified
- Jan 2013
- First submitted
- 31 Jul 2007
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT00510575
- Acronym / sponsor ID
- SHCLA-0123
- Conditions
- Scoliosis
- Keywords
- Juvenile Scoliosis, Adolescent Scoliosis, Scoliosis Management, Spinal Fusion, Scoliosis instrumentation, Juvenile or Adolescent Idiopathic Scoliosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no scientific evidence supporting the superiority of one size rod relative to the other. This study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.
Detailed description
For the correction of Juvenile and Adolescent idiopathic scoliosis, companies offer and surgeons use varying rod sizes not based on scientific evidence, but because of personal preference, availability and company loyalty. To date there has been no literature evaluating the benefit or harm of one rod size versus the other. Our dual-arm prospective study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm stainless steel instrumentation rods. These are both standard rods used in the community for this particular procedure, thus no additional risk exists for the patient. The results of this study will help guide surgeons in their decision making process when faced with the multitude of options offered by implant manufactures.
Comparison(s): 5.5mm stainless steel spinal rod versus 6.35mm stainless steel spinal rod for correction of juvenile and idiopathic scoliosis curves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Spinal rodSubjects in this arm will receive the 5.5mm stainless steel instrumentation rod. |
| 2 | Active comparator | Device: Spinal rodSubjects in this arm will receive a 6.35mm stainless steel instrumentation rod. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of Juvenile or Adolescent Idiopathic Scoliosis
- Anticipated spinal fusion surgery
Key exclusion criteria (2 listed)
- Individuals younger than 11 years and older than 18 years
- Individuals with scoliosis carrying additional diagnoses of illness.
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 |
|---|---|---|
| Spinal rodPosterior spinal fusion using a 5.5 or 6.35 size rod | Device | 1, 2 |
Primary outcome
Radiographic measurements of curve angles and balance.
Time frame: Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
1 secondary outcome
Scoliosis Research Society-30 (SRS-30) questionnaire
Time frame: Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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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.
Norman Otsuka, MD study director
Shriners Hospitals for Children - Los Angeles
Richard Bowen, MD principal investigator
Shriners Hospitals for Children - Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal rod in people with Scoliosis, run by Shriners Hospitals for Children 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 2 inclusion and 2 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 16 Jan 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radiographic measurements of curve angles and balance. (time frame: Pre-operatively, 6 wks post-op, 1 & 2 year post-op.). 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 16 Jan 2013.