Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877236
Status:
WITHDRAWN
Last Update Posted:
2023-11-18
First Post:
2021-04-29
Brief Title:
Green Sun Medical Dynamic Brace
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Pilot Trial Green Sun Medical Dynamic Brace
Status:
WITHDRAWN
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No interest in pursuing study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Green Sun Medical Dynamic Brace GSM brace was developed as an alternative to rigid thoracolumbosacral orthoses TLSOs braces commonly used to prevent continued curve progression in patients with adolescent idiopathic scoliosis AIS The brace applies corrective forces to the muscular and bony structures of the spine while preserving range of motion ROM The innovative design of this brace should provide an equivalent degree of correction of the scoliotic curvature as a rigid TLSO with increased acceptability to the patient via improved comfort and spinalchest wall mobility Increased acceptability promotes increased adherence to treatment This is a pilot study to collect preliminary short-term data concerning the safety and performance of the GSM brace in a sample of subjects with AIS who are currently being treated with a TLSO The study will use clinical exams x-rays monitoring equipment and questionnaires to primarily assess safety and performance Secondary endpoints include spinal ROM and lung vital capacity assessment as well as data validation The study involves 3 visits a performance check phone call and 4 follow up calls over a four month span This is a pilot study and no formal hypothesis testing will be done Descriptive statistics of selected variables will be calculated
Detailed Description:
The Green Sun Medical Dynamic Brace GSM brace was developed as an alternative to rigid thoracolumbosacral orthoses TLSOs braces commonly used to prevent continued curve progression in patients with adolescent idiopathic scoliosis AIS The brace applies corrective forces to the muscular and bony structures of the spine while preserving range of motion ROM The orthosis is prefabricated and adjusted for each patient A series of semi-rigid segments encircle the patients torso in close contact and are joined by a structure of flexible elements These flexible or elastic elements generate stabilizing forces providing the necessary immobilization while allowing relative motion of the semi-rigid segments To date this brace has been tested in the lab on healthy volunteers
The innovative design of this brace should provide an equivalent degree of correction of the scoliotic curvature as a rigid TLSO with increased acceptability to the patient via improved comfort and spinalchest wall mobility Increased acceptability promotes increased adherence to treatment Given the strong research evidence that bracing effectiveness is a function of correction and adherence there is reason to believe that a future pivotal study of the GSM brace could demonstrate superior effectiveness to rigid TLSO designs
This is a pilot study to collect preliminary short-term data concerning the safety and performance of the GSM brace in a sample of subjects with AIS who are currently being treated with a TLSO
In addition this pilot study to provide proof of concept data which will inform further refinements of the GSM brace and support the development of a subsequent pivotal multicenter clinical trial
Our primary aims involve safety and performance
This is a multi-center open-label trial where subjects serve as their own controls Baseline radiographic and patient report will reflect the effect of the subjects standard of care TSLO providing data that can be directly compared to that obtained during use of the GSM brace
Immediately After Consent is Signed and Received by Study Team
The following will be sent to Green Sun so that an appropriately-configured GSM can be made for the subject
1 A de-identified copy of the most recent 3D scan of the patients torso tagged with a study ID number
2 The individualized treatment plan devised by the PI which specifies the location and direction of applied forces eg push on the patients left axilla push on the patients right rib cage roughly 4 inches lateral of midline around T9 and tagged with a study ID number The Baseline Visit will be scheduled approximately 2 weeks after consent is signed and the 3D scan and treatment plan have been sent to Green Sun to allow Green Sun time to fabricate the brace
Instructions for Radiographs
1 All study-related radiographs will be obtained using the EOS Imaging system Micro Dose protocol as available If not Standard of Care measures can be employed
2 The number of study-related radiographs is NOT to exceed 6
3 Three radiographs are required
1 In the TLSO Baseline Visit 1
2 In the GSM Visit 2
3 Out of brace Visit 3
4 A maximum of 3 optional in-brace radiographs may be taken at any time prior to Visit 3 to maximize the fit correction and comfort of the GSM brace
Baseline Visit 1 approximately 2 hours
1 A urine pregnancy test will be conducted Pregnant subjects will exit the study
2 Completion of the Brace Questionnaire and the Italian Spine Youth Quality of Life ISYQOL questionnaire 5 minutes
3 Assessments while wearing current TLSO
1 Vital capacity using Spiropet spirometer average of 3 trials 5 minutes
2 Measurement of spine range-of-motion flexion extension rotation using a tape measure 5 minutes
3 In-brace standing coronal full-spine radiograph 5 minutes
4 The subject will be fitted with the customized GSM brace The fit and corrective forces will be fine-tuned by adjusting the drive mechanisms until the corrective forces are matched to the surface anatomy of the patient and to the spinal deformity The subject is involved in this process by providing feedback concerning the comfort of the brace and the brace cover A log will be kept of all adjustments made to the brace during the course of the study The brace will include the embedded force and acceleration sensors as well as two temperature monitor Orthotimer or iButton units
5 Assessments while wearing Green Sun Brace
1 Vital capacity using Spiropet average of 3 trials 5 minutes
2 Measurement of spine range-of-motion flexion extension rotation using a tape measure 5 minutes
6 Subject sent home with daily GSM Brace Diary
7 Extraction of data from medicalorthotic records date of birth gender date of menses onset and historical measures of height weight skeletal maturity Risser grade status of triradiate Scoliosis Research Society curve classification Cobb angles kyphosis lordosis coronal and sagittal balance apical vertebral rotation in-brace Cobb angles and estimated brace wear time Data from TLSO brace initiation to baseline study visit will be extracted These data define the spinal deformity and the risk for continued progression
8 OPTIONAL Subject Appraisal of the GSM Brace Wear Mobile App Subjects will be given the option to use and provide feedback concerning the GSM mobile app Dynamic Scoliosis Brace Monitoring App Version 151 developed by Green Sun Medical and Mindset Medical This app pairs the subjects mobile device with the GSM sensor in the brace and offloads date accelerometer and pressure sensor data to estimate the number of hours per day that the brace is being worn by the patient The app graphically displays the estimated hoursday the brace was worn for the current day and for the week The app provides real-time feedback using graphical displays that should be easily understandable by adolescents There is research evidence that providing subjects with brace wear time feedback results in better compliance to brace wear recommendations 9 16 Subjects will be given the option to use the app and to complete the GSM App feedback form at Visit 2 and Visit 3 The purpose of the app in this study is not to assess brace wear time or the influence of the app on wear time but only to gather subjects opinions for ongoing refinement of the app The accuracy or reliability of the app is not being tested in this study Subject PHI will not be used for registration subjects will be instructed to enter their Study ID and City instead of their First and Last names DOB as January 1 2019 their email will be entered as the StudyIDgreensunmedicalcom More information about the app is provided in the section Additional Information on Assessments
Visit 2 1-2 weeks after Baseline approximately 1 hour
1 Standing coronal full-spine radiographs in the GSM brace 5 minutes
2 Completion of GSM App Feedback Questionnaire optional
3 Safety Check Query for adverse events and other issues
4 Performance Check
1 If the Cobb angle obtained in the GSM brace is less than or no more than 10 degrees greater than that measured in the TLSO measurement from Baseline Visit 1 then the GSM in-brace correction will be considered equivalent to the standard brace and the subject will be sent home for a 2-week trial of the GSM brace
2 If the in-brace Cobb angle is 10 degrees than that in the TLSO the subject will exit the trial and continue with their current TLSO
5 The subject will be provided with instructions for removal of the first iButton from the GSM brace 2 weeks following their Baseline visit corresponding to the storage capacity of the sensors along with mailing labels and envelopes and GSM brace diaries
Phone Visit and Performance Check 2 weeks after baseline
1 Study staff will contact the subject and parentguardian to see how well the subject is adapting to the GSM brace and remind the subjectparent to remove the temperature monitor from the brace and send by courier overnight to the study site
2 Safety Check Query for adverse events and other issues
3 Performance Check - to insure adherence to prescribed number of hours per day in the GSM brace
1 If any problems are noted during the phone contact the PI will determine whether adjustments to the brace could alleviate the issues and if so ask the subject return to clinic 2 If the temperature monitor data indicate the subject is wearing the GSM brace an average of 2 or more hours less per day than prescribed
1 The PI will determine whether adjustments to the brace could alleviate the issues and have the subject return to clinic if not the subject will exit the study and return to their current TLSO
2 If after adjustments to the brace the subject feels that the brace is still incompatible with the prescribed wear time the subject will exit the study and return to their current TLSO
Phone Visits Weeks 4 6 8 and 10 after baseline
1 Study staff will contact the subject and parentguardian to see how well the subject is adapting to the GSM brace and remind the subject to continue filling out and sending in diaries to the study site in prepaid envelopes
2 Safety Check Query for adverse events and other issues
Visit 3 3-4 months after baseline approximately 1 hour
1 Standing coronal full-spine radiographs out of the brace and measurement of the Cobb angle
2 Removal of iButton 2 and download of temperature monitor data
3 Collection of GSM Brace Diary
4 Completion of the Brace Questionnaire and the Italian Spine Youth Quality of Life ISYQOL questionnaire
5 Completion of GSM App Feedback Questionnaire optional
6 Safety Check Query for adverse events and other issues
7 Performance Check
1 If the Cobb angle measures no more than 10 degrees greater than that obtained from the subjects most recent out of brace radiograph prior to enrollment we will conclude the curve is stable or has progressed within the expected limit If not the subject will resume use of the TLSO
2 If curve stabilization is seen subjects may opt to continue the GSM brace or resume use of their TLSO based on subject and parent preferences
Ongoing Evaluations after Visit 3 following the standard-of-care until GSM brace is discontinued For subjects continuing to use the GSM brace after Visit 3 Subject clinical care and evaluations x-rays clinical exams after Visit 3 will be limited to that typically performed as the standard of care SOC The exception to the SOC will be the administration of the BrQ and ISYQOL at the end of treatment ongoing monitoring and recording of AEs discovered during routine clinic visits or other communications and temperature monitoring at sites where this is not typically SOC Clinical and radiographic data from these visits will be collected for study purposes height weight onset of menses Cobb angles kyphosis lordosis coronal and sagittal balance apical vertebral rotation in-brace Cobb angles and skeletal maturity indicators as available
GSM brace treatment will be discontinued using individualized SOC parameters such as Cobb angle and skeletal maturity indicators at which time the subject will exit the study
Exit From Study Subjects will exit the study upon occurrence of the following events
1 Visit 2 GSM in-brace Cobb is 10 more than the TLSO in-brace Cobb
2 Subject not wearing or tolerating GSM brace per temperature monitor reading 2 weeks after baseline or at any time during study period
3 Visit 3 GSM out-of-brace Cobb indicates curve progression
4 GSM brace is discontinued using standard of care criteria
The innovative design of this brace should provide an equivalent degree of correction of the scoliotic curvature as a rigid TLSO with increased acceptability to the patient via improved comfort and spinalchest wall mobility Increased acceptability promotes increased adherence to treatment Given the strong research evidence that bracing effectiveness is a function of correction and adherence there is reason to believe that a future pivotal study of the GSM brace could demonstrate superior effectiveness to rigid TLSO designs
This is a pilot study to collect preliminary short-term data concerning the safety and performance of the GSM brace in a sample of subjects with AIS who are currently being treated with a TLSO
In addition this pilot study to provide proof of concept data which will inform further refinements of the GSM brace and support the development of a subsequent pivotal multicenter clinical trial
Our primary aims involve safety and performance
This is a multi-center open-label trial where subjects serve as their own controls Baseline radiographic and patient report will reflect the effect of the subjects standard of care TSLO providing data that can be directly compared to that obtained during use of the GSM brace
Immediately After Consent is Signed and Received by Study Team
The following will be sent to Green Sun so that an appropriately-configured GSM can be made for the subject
1 A de-identified copy of the most recent 3D scan of the patients torso tagged with a study ID number
2 The individualized treatment plan devised by the PI which specifies the location and direction of applied forces eg push on the patients left axilla push on the patients right rib cage roughly 4 inches lateral of midline around T9 and tagged with a study ID number The Baseline Visit will be scheduled approximately 2 weeks after consent is signed and the 3D scan and treatment plan have been sent to Green Sun to allow Green Sun time to fabricate the brace
Instructions for Radiographs
1 All study-related radiographs will be obtained using the EOS Imaging system Micro Dose protocol as available If not Standard of Care measures can be employed
2 The number of study-related radiographs is NOT to exceed 6
3 Three radiographs are required
1 In the TLSO Baseline Visit 1
2 In the GSM Visit 2
3 Out of brace Visit 3
4 A maximum of 3 optional in-brace radiographs may be taken at any time prior to Visit 3 to maximize the fit correction and comfort of the GSM brace
Baseline Visit 1 approximately 2 hours
1 A urine pregnancy test will be conducted Pregnant subjects will exit the study
2 Completion of the Brace Questionnaire and the Italian Spine Youth Quality of Life ISYQOL questionnaire 5 minutes
3 Assessments while wearing current TLSO
1 Vital capacity using Spiropet spirometer average of 3 trials 5 minutes
2 Measurement of spine range-of-motion flexion extension rotation using a tape measure 5 minutes
3 In-brace standing coronal full-spine radiograph 5 minutes
4 The subject will be fitted with the customized GSM brace The fit and corrective forces will be fine-tuned by adjusting the drive mechanisms until the corrective forces are matched to the surface anatomy of the patient and to the spinal deformity The subject is involved in this process by providing feedback concerning the comfort of the brace and the brace cover A log will be kept of all adjustments made to the brace during the course of the study The brace will include the embedded force and acceleration sensors as well as two temperature monitor Orthotimer or iButton units
5 Assessments while wearing Green Sun Brace
1 Vital capacity using Spiropet average of 3 trials 5 minutes
2 Measurement of spine range-of-motion flexion extension rotation using a tape measure 5 minutes
6 Subject sent home with daily GSM Brace Diary
7 Extraction of data from medicalorthotic records date of birth gender date of menses onset and historical measures of height weight skeletal maturity Risser grade status of triradiate Scoliosis Research Society curve classification Cobb angles kyphosis lordosis coronal and sagittal balance apical vertebral rotation in-brace Cobb angles and estimated brace wear time Data from TLSO brace initiation to baseline study visit will be extracted These data define the spinal deformity and the risk for continued progression
8 OPTIONAL Subject Appraisal of the GSM Brace Wear Mobile App Subjects will be given the option to use and provide feedback concerning the GSM mobile app Dynamic Scoliosis Brace Monitoring App Version 151 developed by Green Sun Medical and Mindset Medical This app pairs the subjects mobile device with the GSM sensor in the brace and offloads date accelerometer and pressure sensor data to estimate the number of hours per day that the brace is being worn by the patient The app graphically displays the estimated hoursday the brace was worn for the current day and for the week The app provides real-time feedback using graphical displays that should be easily understandable by adolescents There is research evidence that providing subjects with brace wear time feedback results in better compliance to brace wear recommendations 9 16 Subjects will be given the option to use the app and to complete the GSM App feedback form at Visit 2 and Visit 3 The purpose of the app in this study is not to assess brace wear time or the influence of the app on wear time but only to gather subjects opinions for ongoing refinement of the app The accuracy or reliability of the app is not being tested in this study Subject PHI will not be used for registration subjects will be instructed to enter their Study ID and City instead of their First and Last names DOB as January 1 2019 their email will be entered as the StudyIDgreensunmedicalcom More information about the app is provided in the section Additional Information on Assessments
Visit 2 1-2 weeks after Baseline approximately 1 hour
1 Standing coronal full-spine radiographs in the GSM brace 5 minutes
2 Completion of GSM App Feedback Questionnaire optional
3 Safety Check Query for adverse events and other issues
4 Performance Check
1 If the Cobb angle obtained in the GSM brace is less than or no more than 10 degrees greater than that measured in the TLSO measurement from Baseline Visit 1 then the GSM in-brace correction will be considered equivalent to the standard brace and the subject will be sent home for a 2-week trial of the GSM brace
2 If the in-brace Cobb angle is 10 degrees than that in the TLSO the subject will exit the trial and continue with their current TLSO
5 The subject will be provided with instructions for removal of the first iButton from the GSM brace 2 weeks following their Baseline visit corresponding to the storage capacity of the sensors along with mailing labels and envelopes and GSM brace diaries
Phone Visit and Performance Check 2 weeks after baseline
1 Study staff will contact the subject and parentguardian to see how well the subject is adapting to the GSM brace and remind the subjectparent to remove the temperature monitor from the brace and send by courier overnight to the study site
2 Safety Check Query for adverse events and other issues
3 Performance Check - to insure adherence to prescribed number of hours per day in the GSM brace
1 If any problems are noted during the phone contact the PI will determine whether adjustments to the brace could alleviate the issues and if so ask the subject return to clinic 2 If the temperature monitor data indicate the subject is wearing the GSM brace an average of 2 or more hours less per day than prescribed
1 The PI will determine whether adjustments to the brace could alleviate the issues and have the subject return to clinic if not the subject will exit the study and return to their current TLSO
2 If after adjustments to the brace the subject feels that the brace is still incompatible with the prescribed wear time the subject will exit the study and return to their current TLSO
Phone Visits Weeks 4 6 8 and 10 after baseline
1 Study staff will contact the subject and parentguardian to see how well the subject is adapting to the GSM brace and remind the subject to continue filling out and sending in diaries to the study site in prepaid envelopes
2 Safety Check Query for adverse events and other issues
Visit 3 3-4 months after baseline approximately 1 hour
1 Standing coronal full-spine radiographs out of the brace and measurement of the Cobb angle
2 Removal of iButton 2 and download of temperature monitor data
3 Collection of GSM Brace Diary
4 Completion of the Brace Questionnaire and the Italian Spine Youth Quality of Life ISYQOL questionnaire
5 Completion of GSM App Feedback Questionnaire optional
6 Safety Check Query for adverse events and other issues
7 Performance Check
1 If the Cobb angle measures no more than 10 degrees greater than that obtained from the subjects most recent out of brace radiograph prior to enrollment we will conclude the curve is stable or has progressed within the expected limit If not the subject will resume use of the TLSO
2 If curve stabilization is seen subjects may opt to continue the GSM brace or resume use of their TLSO based on subject and parent preferences
Ongoing Evaluations after Visit 3 following the standard-of-care until GSM brace is discontinued For subjects continuing to use the GSM brace after Visit 3 Subject clinical care and evaluations x-rays clinical exams after Visit 3 will be limited to that typically performed as the standard of care SOC The exception to the SOC will be the administration of the BrQ and ISYQOL at the end of treatment ongoing monitoring and recording of AEs discovered during routine clinic visits or other communications and temperature monitoring at sites where this is not typically SOC Clinical and radiographic data from these visits will be collected for study purposes height weight onset of menses Cobb angles kyphosis lordosis coronal and sagittal balance apical vertebral rotation in-brace Cobb angles and skeletal maturity indicators as available
GSM brace treatment will be discontinued using individualized SOC parameters such as Cobb angle and skeletal maturity indicators at which time the subject will exit the study
Exit From Study Subjects will exit the study upon occurrence of the following events
1 Visit 2 GSM in-brace Cobb is 10 more than the TLSO in-brace Cobb
2 Subject not wearing or tolerating GSM brace per temperature monitor reading 2 weeks after baseline or at any time during study period
3 Visit 3 GSM out-of-brace Cobb indicates curve progression
4 GSM brace is discontinued using standard of care criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None