ScoliosisNCT00577226
Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine
An observational study of Scoliosis, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The objective of this study is to retrospectively and prospectively review patients who have undergone this technique looking at age of the patient, magnitude of the curve preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical procedures, complications, and spinal growth. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Scoliosis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2015
- Phase
- Observational
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: The patients whose data is observed are those who have undergone the shilla surgical technique.
Who may be able to join
- between the ages of 1 yr and 10 yrs
- have severe, progressive scoliosis unresponsive to bracing
- have severe, progressive scoliosis who cannot tolerate bracing
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Childrens Hospital
Little Rock, Arkansas, 72202
About this study
Official title: Use of the Shilla Growth Permitting Spinal Instrumentation System/Technique for the Treatment of Scoliosis in the Immature Spine
The objective of this study is to retrospectively and prospectively review patients who have undergone this technique looking at age of the patient, magnitude of the curve preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical procedures, complications, and spinal growth.
The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for natural growth of the spine in a guided fashion with a limited number of future surgeries required.
Read the detailed description
Traditional "growing rod" constructs of spinal instrumentation to treat severe scoliosis in young children require a return to the operating room every six to nine months until skeletal maturity. The Shilla system allows for more spinal growth with fewer surgical procedures necessary for lengthenings. This is a major advantage over existing growth permitting systems and allows surgery to be performed at younger ages with better deformity correction without concerns of repeated surgeries.
- Conditions
- Scoliosis
- Keywords
- scoliosis, immature spine
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 Shilla Technique | The patients whose data is observed are those who have undergone the shilla surgical technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs.
Measured: 5 yrs
Secondary outcomes (1)
Patients will have continued spinal growth
Measured: 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startApr 2005
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: IRB has requested additional information regarding IDE
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard E. McCarthy, M.D., Principal investigator, University of Arkansas for Medical Sciences/Arkansas Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577226
- Sponsor's protocol ID
- 32975
- Status last verified
- May 2016
- First submitted
- 18 Dec 2007
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Shilla Growth Permitting Spinal Instrumentation System/Technique for the Treatment of Scoliosis in the Immature Spine
- ClinicalTrials.gov ID
- NCT00577226
- Acronym / sponsor ID
- 32975
- Conditions
- Scoliosis
- Keywords
- scoliosis, immature spine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB has requested additional information regarding IDE
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Dec 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.
The objective of this study is to retrospectively and prospectively review patients who have undergone this technique looking at age of the patient, magnitude of the curve preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical procedures, complications, and spinal growth.
The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for natural growth of the spine in a guided fashion with a limited number of future surgeries required.
Detailed description
Traditional "growing rod" constructs of spinal instrumentation to treat severe scoliosis in young children require a return to the operating room every six to nine months until skeletal maturity. The Shilla system allows for more spinal growth with fewer surgical procedures necessary for lengthenings. This is a major advantage over existing growth permitting systems and allows surgery to be performed at younger ages with better deformity correction without concerns of repeated surgeries.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Shilla Technique | – | –The patients whose data is observed are those who have undergone the shilla surgical technique. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The patients whose data is observed are those who have undergone the shilla surgical technique.
Key inclusion criteria (3 listed)
- between the ages of 1 yr and 10 yrs
- have severe, progressive scoliosis unresponsive to bracing
- have severe, progressive scoliosis who cannot tolerate bracing
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs.
Time frame: 5 yrs
1 secondary outcome
Patients will have continued spinal growth
Time frame: 5 yrs
Results and safety
The study was stopped early (reason given: IRB has requested additional information regarding IDE). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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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.
Richard E. McCarthy, M.D. principal investigator
University of Arkansas for Medical Sciences/Arkansas Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Arkansas Children's Hospital Research Institute 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 May 2016. 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?
The study was stopped early (reason given: IRB has requested additional information regarding IDE). Results are not available in the source record.
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?
Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs. (time frame: 5 yrs). 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 5 May 2016.