Trial Outcomes & Findings for Green Sun Medical Dynamic Scoliosis Brace (NCT NCT03641469)

Results Overview

Acceptable GSM in-brace correction was defined as a difference of 10 degrees or less between the TLSO and GSM in-brace Cobb angles.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days

Results posted on

2025-06-12

Participant Flow

36 patients with AIS were enrolled at 6 centers across the US. Recruitment opened May 2018 and continued until January 2024. Enrollment and study procedures were interrupted for several months by COVID in 2020.

Participant milestones

Participant milestones
Measure	Green Sun Dynamic Brace TLSO at Baseline followed by GSM brace for 3 months
Overall Study STARTED	36
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Green Sun Dynamic Brace TLSO at Baseline followed by GSM brace for 3 months
Overall Study Ineligible	2
Overall Study Withdrawal by Subject	5
Overall Study Physician Decision	1
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Green Sun Dynamic Brace n=34 Participants Eligible subjects treated with a TLSO at baseline
Age, Categorical <=18 years	34 Participants n=34 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=34 Participants
Age, Categorical >=65 years	0 Participants n=34 Participants
Sex: Female, Male Female	34 Participants n=34 Participants
Sex: Female, Male Male	0 Participants n=34 Participants
Region of Enrollment United States	34 participants n=34 Participants
Out-of-brace Cobb angle at Baseline	30.68 degrees STANDARD_DEVIATION 9.16 • n=28 Participants • Baseline Cobb angle measurements (from x-ray taken within 180 days prior to baseline) not available for 6 subjects

PRIMARY outcome

Timeframe: Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days

Population: 24 subjects had x-rays in the TLSO and the GSM taken within a 60-day time frame.

Acceptable GSM in-brace correction was defined as a difference of 10 degrees or less between the TLSO and GSM in-brace Cobb angles.

Outcome measures

Outcome measures
Measure	Green Sun Dynamic Brace n=24 Participants Patients transitioned from current TLSO to GSM brace
Percentage of Participants With Acceptable GSM In-Brace Correction	100 Percentage acceptable GSM correction

PRIMARY outcome

Timeframe: Baseline to ~3 mo Follow-up

Population: 28 patients had baseline out-of-brace x-rays taken within 6 months of enrollment

Curve stability is defined as progression of 10 degrees or less between the Cobb angle at baseline and at follow-up after GSM wear (Baseline Cobb angle minus follow-up Cobb angle).

Outcome measures

Outcome measures
Measure	Green Sun Dynamic Brace n=20 Participants Patients transitioned from current TLSO to GSM brace
Percentage of Participants With Curve Stability or Progression at 3-month Follow-up	18 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues

Outcome measures

Outcome measures
Measure	Green Sun Dynamic Brace n=34 Participants Patients transitioned from current TLSO to GSM brace
Unanticipated Adverse Events	1 number of AE's reported

SECONDARY outcome

Timeframe: Baseline to Visit 3 (3-4 months post-baseline)

Population: 14 subjects with both baseline and follow-up BrQ scores for analysis.

Change in Brace Questionnaire (BrQ) scores from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). Total scores range from 20 to 100, with higher scores suggesting better quality-of-life during bracing. A positive change score suggests increased brace-related QOL related to exposure to the GSM brace.

Outcome measures

Outcome measures
Measure	Green Sun Dynamic Brace n=14 Participants Patients transitioned from current TLSO to GSM brace
Change in Brace-related Quality of Life Scores (Brace Questionnaire)	3.82 Units on the scale Interval -17.37 to 21.1

SECONDARY outcome

Timeframe: Baseline to Visit 3 (3-4 months post-baseline)

Population: 12 subjects had baseline and follow-up ISYQOL scores for analysis

Change in scores on the Italian Spine Youth Quality of Life (ISYQOL) measure from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). The total scores range from 0 to 100% where 100% indicates no problems related to spine or bracing issues. A positive change score suggests increased QOL related to exposure to the GSM brace.

Outcome measures

Outcome measures
Measure	Green Sun Dynamic Brace n=12 Participants Patients transitioned from current TLSO to GSM brace
Change in Quality of Life Scores	5.36 change in percentage QOL Interval -19.02 to 18.55

SECONDARY outcome

Timeframe: Baseline

Population: Participants tested prior to March 2020, after which spirometry testing was stopped due to COVID

Lung vital capacity measured in the TLSO and in the GSM brace to estimate chest wall movement difference. Positive difference favors GSM.

Outcome measures

Outcome measures
Measure	Green Sun Dynamic Brace n=16 Participants Patients transitioned from current TLSO to GSM brace
Difference in Vital Capacity Measured in TLSO and GSM Brace	82.81 milliliters Standard Deviation 470.80

Adverse Events

Green Sun Dynamic Brace

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Green Sun Dynamic Brace n=34 participants at risk Use of the Green Sun Dynamic Brace
Skin and subcutaneous tissue disorders Pressure point of skin related to device	2.9% 1/34 • Number of events 1 • Up to 1 year Any untoward or unfavorable medical occurrence in a participant, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Teams were asked to continuously surveil for AE's during study visits and phone contacts; all AE's were to be reported using a standard case report form. AE's prior to switch to GSM brace at baseline were not recorded.

Additional Information

James A. Arthur

Green Sun Medical

Phone: 720-202-3621

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Agreements are not uniform across the sites. The most restrictive agreement states that the site PI and sponsor agree present results only together with the other clinical study sites unless specific written permission is obtained in advance from Sponsor up to 1 year post-completion. After that, the PI can publish/present independently if Sponsor is given the opportunity to review and comment prior to dissemination.
Publication restrictions are in place

Restriction type: OTHER