ScoliosisNCT01370057
The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)
A study testing Thoraco-lumbo-sacral Orthosis in people with Scoliosis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Thoraco-lumbo-sacral Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Apr 2017
- Phase
- Interventional
- 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed Diagnosis of AIS
- Age ≥10, ≤15 years old
- Risser 0, 1 or 2
- Primary Cobb angle between 20 and 40 degrees (inclusive)
- Apex (of at least one of the primary curves) caudal to T7
- Pre-menarchal OR post-menarchal by ≤1 year
- Physical and mental ability to adhere to bracing protocol
Who cannot join
- Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature
- A history of previous surgical or orthotic treatment
- Inability to read and understand Chinese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study
The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.
- Conditions
- Scoliosis
- Being tested
- Thoraco-lumbo-sacral Orthosis
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis, AIS, Brace, TLSO
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoraco-lumbo-sacral OrthosisDevice
Also called The Thoraco-lumbo-sacral Orthosis is fabricated at Prosthetic & Orthotic Department at our research facility(Prince of Wales Hospital, Hong Kong SAR, China)
Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment with bracing Receives: Device: Thoraco-lumbo-sacral Orthosis |
| Control Group | No intervention | Watchful waiting without bracing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curve progression
Curve progression to Cobb angle of 50 degrees or more
Measured: Till cessation of growth or progression of curve severity to 50 degrees or more, patient will be followed once every 6 months, an average follow up of 3 years is expected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Failure of Subject Recruitment
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.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHENG Chun-yiu Jack, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370057
- Sponsor's protocol ID
- BRAIST HK PROTOCOL VER1
- Status last verified
- Jul 2017
- First submitted
- 20 May 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01370057
- Acronym / sponsor ID
- BRAIST HK PROTOCOL VER1
- Conditions
- Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis, AIS, Brace, TLSO
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure of Subject Recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Jun 2011 (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 purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Thoraco-lumbo-sacral OrthosisTreatment with bracing |
| Control Group | No intervention | –Watchful waiting without bracing |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Confirmed Diagnosis of AIS
- Age ≥10, ≤15 years old
- Risser 0, 1 or 2
- Primary Cobb angle between 20 and 40 degrees (inclusive)
- Apex (of at least one of the primary curves) caudal to T7
Key exclusion criteria (3 listed)
- Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature
- A history of previous surgical or orthotic treatment
- Inability to read and understand Chinese
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 |
|---|---|---|
| Thoraco-lumbo-sacral OrthosisAlso: The Thoraco-lumbo-sacral Orthosis is fabricated at Prosthetic & Orthotic Department at our research facility(Prince of Wales Hospital, Hong Kong SAR, China)Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis | Device | Treatment Group |
Primary outcome
Curve progression
Time frame: Till cessation of growth or progression of curve severity to 50 degrees or more, patient will be followed once every 6 months, an average follow up of 3 years is expected
Curve progression to Cobb angle of 50 degrees or more
Results and safety
The study was stopped early (reason given: Failure of Subject Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoraco-lumbo-sacral Orthosis in people with Scoliosis, run by Chinese University of Hong Kong at 1 site in China.
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 7 inclusion and 3 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 21 Jul 2017. 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 China. 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: Failure of Subject Recruitment). 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?
Curve progression (time frame: Till cessation of growth or progression of curve severity to 50 degrees or more, patient will be followed once every 6 months, an average follow up of 3 years is expected). 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 21 Jul 2017.