Adolescence Idiopathic ScoliosisNCT02227537
Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
An observational study of Adolescence Idiopathic Scoliosis, run by OrthoGeorgia at 2 sites in United States.
Trial summary
A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Adolescence Idiopathic Scoliosis
- What is being tested?
- Providence Nighttime Bracing System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Aug 2016
- 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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: up to 100 adolescent male/female will be enrolled at up to 4 sites in the US. Patients must be at least 10 years of age. Participants who receive treatment must have been diagnosed with adolescent idiopathic scoliosis without other significant spinal pathology. Appropriate participant selection will be accomplished through the integration of clinical and radiological parameters while ruling out other confounding sources of back pain or curvature. Subjects will be included who demonstrate a Cobb angle between 25-40 degrees. Participants must have radiographic evidence of a Risser grade of 0, 1, or 2. All chronic disease process and other possible sources for spinal curvature will be excluded by thorough history and physical examination.
Who may be able to join
- Subject/guardian is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
- Clinical/radiographic diagnosis of adolescence idiopathic scoliosis;
- Male/female;
- Skeletally immature (Risser grade 0, 1, or 2);
- Cobb angle between 25-40 degrees;
- Pre-menarchal or post-menarchal by no more than 1 year at the time of diagnosis;
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- Curve apex caudal to T6 vertebrae;
- Physical and mental ability to adhere to bracing protocol;
- Have agreed to refuse participation in another clinical trial for the duration of the study.
Who cannot join
- History of previous surgical intervention or other invasive treatment for AIS;
- History of orthotic treatment or other brace wear for the treatment of AIS;
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature;
- Tumor or malignant tumor in the spine;
- Inability to communicate clearly in the English language;
- Subjects with a Risser score ≥ 3;
- Plans to relocate within the next 2 years;
- Any subject the Principle Investigator deems as an unfit candidate.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Georgia Pediatric Orthopaedics
Macon, Georgia, 31201
Craig C Odum, 478-254-5377, codum@orthoga.org
- Recruiting
OrthoGeorgia
Macon, Georgia, 31201
Craig C Odum, 478-254-5377, codum@orthoga.org
About this study
A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.
Read the detailed description
This study is designed as a multicenter, prospective, non-randomized, single arm observational study. A temperature probe and data logger will be attached to the Providence brace to monitor patient compliance wear time. Subjects will be blinded to temperature sensor readings to maximize objectivity of brace wear.
- Conditions
- Adolescence Idiopathic Scoliosis
- Being tested
- Providence Nighttime Bracing System
- Keywords
- Adolescence Idiopathic Scoliosis, nighttime Bracing, Providence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providence Nighttime Bracing SystemDevice
Providence Nighttime Bracing System
Providence Nighttime Bracing SystemDevice
The Providence brace is a polypropylene plastic, acrylic framed, system designed to apply corrective forces to scoliatic curves achieving correction or reduction of scoliosis.
| Study group | Role | What they receive |
|---|---|---|
| Adolescence idiopathic scoliosis | Patients must be at least 10 years of age with a risser score of 0, 1, or 2 Receives: Device: Providence Nighttime Bracing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curve progression
- The percentage of patients who have ≤5o curve progression and the percentage of patients who have ≥6 o progression at maturity;
- The percentage of patients with curves exceeding 45o at maturity and the percentage who have had surgery recommended/undergone;
- 2 year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery.
Routine follow-up visits will be scheduled 6 months apart (1st visit after brace fitting, 6, 12, 18 and 24 months) up to 24 months. At each of these visits, the patient will undergo a history \& physical, PA radiographs, Cobb Angle assessment, Adams Forward Bending test, Neurological examination, outcome questionnaire's, concomitant medications, and adverse event recordings.
Measured: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Secondary outcomes (3)
Compliance
A temperature data logger will record and monitor patient compliance of brace wear. To not create undue awareness to these recordings patients will be informed the temperature readings are being monitored for patient comfort and ease of brace wear. Reconciliation of data logger recordings will be conducted every 3 months.
Measured: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Functionality
Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI ("Pediatric Outcomes Data Collection Instrument")
Measured: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
physical health and personal image
Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI ("Pediatric Outcomes Data Collection Instrument")
Measured: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescence 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoGeorgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Dasher, MD, OrthoGeorgia
- Investigators
- William B Dasher, MD, Principal investigator, OrthoGeorgiaEric D Lincoln, DO, Principal investigator, Georgia Pediatric OrthopaedicsWinston R Jeshuran, MD, Principal investigator, OrthoGeorgiaWayne Kelley, MD, Principal investigator, OrthoGeorgiaRandolph Devereaux, PhD, Principal investigator, Mercer University School of MedicineHamza H Awad, MD, PhD, Principal investigator, Mercer University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227537
- Sponsor's protocol ID
- OG12-04-13
- Status last verified
- Apr 2015
- First submitted
- 22 Aug 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02227537
- Acronym / sponsor ID
- OG12-04-13
- Conditions
- Adolescence Idiopathic Scoliosis
- Keywords
- Adolescence Idiopathic Scoliosis, nighttime Bracing, Providence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- OrthoGeorgiaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 28 Aug 2014 (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.
A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.
Detailed description
This study is designed as a multicenter, prospective, non-randomized, single arm observational study. A temperature probe and data logger will be attached to the Providence brace to monitor patient compliance wear time. Subjects will be blinded to temperature sensor readings to maximize objectivity of brace wear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescence idiopathic scoliosis | – | Device: Providence Nighttime Bracing SystemPatients must be at least 10 years of age with a risser score of 0, 1, or 2 |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- up to 100 adolescent male/female will be enrolled at up to 4 sites in the US. Patients must be at least 10 years of age. Participants who receive treatment must have been diagnosed with adolescent idiopathic scoliosis without other significant spinal pathology. Appropriate participant selection will be accomplished through the integration of clinical and radiological parameters while ruling out other confounding sources of back pain or curvature. Subjects will be included who demonstrate a Cobb angle between 25-40 degrees. Participants must have radiographic evidence of a Risser grade of 0, 1, or 2. All chronic disease process and other possible sources for spinal curvature will be excluded by thorough history and physical examination.
Key inclusion criteria (9 listed)
- Subject/guardian is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
- Clinical/radiographic diagnosis of adolescence idiopathic scoliosis;
- Male/female;
- Skeletally immature (Risser grade 0, 1, or 2);
- Cobb angle between 25-40 degrees;
Key exclusion criteria (8 listed)
- History of previous surgical intervention or other invasive treatment for AIS;
- History of orthotic treatment or other brace wear for the treatment of AIS;
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature;
- Tumor or malignant tumor in the spine;
- Inability to communicate clearly in the English language;
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 |
|---|---|---|
| Providence Nighttime Bracing SystemProvidence Nighttime Bracing System | Device | Adolescence idiopathic scoliosis |
| Providence Nighttime Bracing SystemThe Providence brace is a polypropylene plastic, acrylic framed, system designed to apply corrective forces to scoliatic curves achieving correction or reduction of scoliosis. | Device | Adolescence idiopathic scoliosis |
Primary outcome
Curve progression
Time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
* The percentage of patients who have ≤5o curve progression and the percentage of patients who have ≥6 o progression at maturity; * The percentage of patients with curves exceeding 45o at maturity and the percentage who have had surgery recommended/undergone; * 2 year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery. Routine follow-up visits will be scheduled 6 months apart (1st visit after brace fitting, 6, 12, 18 and 24 months) up to 24 months. At each of these visits, the patient will undergo a history \& physical, PA radiographs, Cobb Angle assessment, Adams Forward Bending test, Neurological examination, outcome questionnaire's, concomitant medications, and adverse event recordings.
3 secondary outcomes
Compliance
Time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Functionality
Time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
physical health and personal image
Time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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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.
William B Dasher, MD principal investigator
OrthoGeorgia
Eric D Lincoln, DO principal investigator
Georgia Pediatric Orthopaedics
Winston R Jeshuran, MD principal investigator
OrthoGeorgia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescence Idiopathic Scoliosis, run by OrthoGeorgia at 2 sites 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig C Odum (478-254-5377, codum@orthoga.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curve progression (time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system). 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 Apr 2015.