Trial Outcomes & Findings for Vertebral Body Tethering Outcomes for Pediatric Idiopathic Scoliosis (NCT NCT03194568)
NCT ID: NCT03194568
Last Updated: 2024-09-23
Results Overview
Intra-operative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are "device-related" and "non device-related".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
up to 2 years
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
Anterior Vertebral Tethering
Subjects receiving Anterior Vertebral Tethering intervention.
Anterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Anterior Vertebral Tethering
Subjects receiving Anterior Vertebral Tethering intervention.
Anterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
|
|---|---|
|
Overall Study
Withdrawn due to need for re-operation related to an anticipated device SAE
|
4
|
Baseline Characteristics
Lumbar bending X-Ray not taken for 1 subject at baseline
Baseline characteristics by cohort
| Measure |
Anterior Vertebral Tethering
n=20 Participants
Subjects receiving Anterior Vertebral Tethering intervention.
Anterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
|
|---|---|
|
Age, Continuous
|
12 years
STANDARD_DEVIATION 1.94 • n=20 Participants
|
|
Age, Customized
Age at first diagnosis of Idiopathic Scoliosis
|
9 years
STANDARD_DEVIATION 2.38 • n=20 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
|
Menarche status
Yes
|
6 Participants
n=20 Participants
|
|
Menarche status
No
|
10 Participants
n=20 Participants
|
|
Menarche status
N/A, Male
|
4 Participants
n=20 Participants
|
|
Height (cm)
|
159.4 cm
STANDARD_DEVIATION 12.43 • n=20 Participants
|
|
Weight (kg)
|
45.8 kg
STANDARD_DEVIATION 13.82 • n=20 Participants
|
|
Degree of thoracic rib hump
|
13 Degrees
STANDARD_DEVIATION 4.64 • n=20 Participants
|
|
Thoracic Rib Hump Side
Right
|
20 Participants
n=20 Participants
|
|
Thoracic Rib Hump Side
Left
|
0 Participants
n=20 Participants
|
|
Degree of lumbar rib hump
|
6 Degrees
STANDARD_DEVIATION 2.72 • n=20 Participants
|
|
Lumbar rib hump side
Left
|
20 Participants
n=20 Participants
|
|
Lumbar rib hump side
Right
|
0 Participants
n=20 Participants
|
|
Coronal Thoracic Cobb Angle
|
51.5 Degrees
STANDARD_DEVIATION 7.25 • n=20 Participants
|
|
Coronal Lumbar Cobb Angle
|
29 Degrees
STANDARD_DEVIATION 6.77 • n=20 Participants
|
|
Bending Thoracic Cobb Angle
|
20.5 Degrees
STANDARD_DEVIATION 10.56 • n=20 Participants
|
|
Bending Lumbar Cobb Angle
|
5 Degrees
STANDARD_DEVIATION 9.83 • n=19 Participants • Lumbar bending X-Ray not taken for 1 subject at baseline
|
|
Sanders Bone Age
0
|
0 Participants
n=20 Participants
|
|
Sanders Bone Age
1
|
0 Participants
n=20 Participants
|
|
Sanders Bone Age
2
|
2 Participants
n=20 Participants
|
|
Sanders Bone Age
3
|
10 Participants
n=20 Participants
|
|
Sanders Bone Age
4
|
8 Participants
n=20 Participants
|
|
Sanders Bone Age
5
|
0 Participants
n=20 Participants
|
|
Sanders Bone Age
6
|
0 Participants
n=20 Participants
|
|
Sanders Bone Age
7
|
0 Participants
n=20 Participants
|
|
Sanders Bone Age
8
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: Four of the subjects were withdrawn from the study prior to the 2 year completion date due to need for re-operation related to an anticipated device SAE. All data reported for these subjects were obtained prior to withdrawal.
Intra-operative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are "device-related" and "non device-related".
Outcome measures
| Measure |
Anterior Vertebral Tethering
n=20 Participants
Subjects receiving Anterior Vertebral Tethering intervention.
Anterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
|
|---|---|
|
Incidence of Treatment-Emergent Adverse Events
Subjects that experienced a device-related AE
|
11 Participants
|
|
Incidence of Treatment-Emergent Adverse Events
Subjects that experienced a device-related SAE
|
7 Participants
|
|
Incidence of Treatment-Emergent Adverse Events
Subjects that experienced a non-device related AE
|
20 Participants
|
|
Incidence of Treatment-Emergent Adverse Events
Subjects that experienced a non-device related SAE
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Four of the subjects were withdrawn from the study prior to the 2 year completion date due to need for re-operation related to an anticipated device SAE. All data reported for these subjects were obtained prior to withdrawal.
The exploratory therapeutic endpoint used for feasibility will be change in post-operative Cobb angle compared to pre-operative Cobb angle, measured on coronal radiograph of the spine.
Outcome measures
| Measure |
Anterior Vertebral Tethering
n=20 Participants
Subjects receiving Anterior Vertebral Tethering intervention.
Anterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
|
|---|---|
|
Comparison of Pre-Operative and Post-Operative Cobb Angle
Thoracic curve <50° without a secondary spinal fusion or other revision surgery
|
14 Participants
|
|
Comparison of Pre-Operative and Post-Operative Cobb Angle
Thoracic curve >50°, or requiring a secondary spinal fusion or other revision surgery
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Four of the 20 initial subjects were withdrawn from the study prior to final follow-up administration of SRS questionnaire.
The Scoliosis Research Society 30 (SRS-30) questionnaire will be administered at pre-operative and post-operative time points. This questionnaire measures health-related quality of life outcomes. It consists of 30 questions divided into five domains: Function/Activity (5 questions), Pain (5 questions), Self-image/Appearance (5 questions), Mental Health (5 questions), and Satisfaction with management (2 questions). The remaining 8 questions are a combination of different domains. Each question is scored on a 5-point scale (1 = worst, 5 = best). To score each domain, sum the scores of the questions within that domain and then divide by the number of questions in that domain to get an average score. To calculate the total overall score, sum all the individual question scores and then divide by the total number of questions (30). Higher scores indicate better health-related quality of life.
Outcome measures
| Measure |
Anterior Vertebral Tethering
n=20 Participants
Subjects receiving Anterior Vertebral Tethering intervention.
Anterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
|
|---|---|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Pre-operative Function/Activity
|
4.4 score on a scale
Standard Deviation 0.4
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Pre-operative Pain
|
4.3 score on a scale
Standard Deviation 0.7
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Pre-operative Self-image/Appearance
|
3.6 score on a scale
Standard Deviation 0.8
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Pre-operative Mental Health
|
4.2 score on a scale
Standard Deviation 0.6
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Pre-operative Satisfaction with management
|
3.5 score on a scale
Standard Deviation 0.9
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Pre-operative total score
|
4.1 score on a scale
Standard Deviation 0.5
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Post-operative Function/Activity
|
4.5 score on a scale
Standard Deviation 0.4
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Post-operative Pain
|
4.6 score on a scale
Standard Deviation 0.5
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Post-operative Self-image/Appearance
|
4.2 score on a scale
Standard Deviation 0.7
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Post-operative Mental Health
|
4.1 score on a scale
Standard Deviation 0.7
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Post-operative Satisfaction with management
|
4.2 score on a scale
Standard Deviation 1.0
|
|
Comparison of Pre-Operative and Post-Operative SRS 30 Scores
Post-operative total score
|
4.3 score on a scale
Standard Deviation 0.5
|
Adverse Events
Anterior Vertebral Tethering
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anterior Vertebral Tethering
n=20 participants at risk
Subjects receiving Anterior Vertebral Tethering intervention.
Anterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
|
|---|---|
|
Injury, poisoning and procedural complications
Grade IIIB
|
30.0%
6/20 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
Other adverse events
| Measure |
Anterior Vertebral Tethering
n=20 participants at risk
Subjects receiving Anterior Vertebral Tethering intervention.
Anterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Grade I
|
100.0%
20/20 • Number of events 56 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
|
Injury, poisoning and procedural complications
Grade II
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
|
Gastrointestinal disorders
Grade I
|
60.0%
12/20 • Number of events 16 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
|
Skin and subcutaneous tissue disorders
Grade I
|
30.0%
6/20 • Number of events 7 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
|
Musculoskeletal and connective tissue disorders
Grade I
|
80.0%
16/20 • Number of events 52 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
|
General disorders
Grade I
|
15.0%
3/20 • Number of events 4 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
|
Cardiac disorders
Grade I
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
|
Psychiatric disorders
Grade I
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
|
Product Issues
Grade I
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place