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Trial Outcomes & Findings for Safety Outcomes of Vertebral Body Tethering Technique (NCT NCT04119284)

NCT ID: NCT04119284

Last Updated: 2025-01-13

Results Overview

We will look for any changes in neurological status, tether failure, implant reoperation, overcorrection and wound infections. Adverse events will be summarized by their severity and frequency and reported to IRB and Data Safety board on timely bases. The PI will determine if these events are related to the device.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

2 years after the surgery

Results posted on

2025-01-13

Participant Flow

Participant milestones

Participant milestones
Measure
Anterior Vertebral Tethering
Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia. Anterior body tether (ABT): To insert the ABT in patients to correct AIS.
Overall Study
STARTED
8
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Outcomes of Vertebral Body Tethering Technique

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Anterior Vertebral Tethering
n=8 Participants
Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia. Anterior body tether (ABT): To insert the ABT in patients to correct AIS.
Age, Continuous
11.34 years
n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
8 participants
n=5 Participants
Cobb angle
48.125 degree
n=5 Participants

PRIMARY outcome

Timeframe: 2 years after the surgery

We will look for any changes in neurological status, tether failure, implant reoperation, overcorrection and wound infections. Adverse events will be summarized by their severity and frequency and reported to IRB and Data Safety board on timely bases. The PI will determine if these events are related to the device.

Outcome measures

Outcome measures
Measure
Anterior Vertebral Tethering
n=8 Participants
Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia. Anterior body tether (ABT): To insert the ABT in patients to correct AIS.
Number of Adverse Events After the Procedure
8 Number of Tether failures

SECONDARY outcome

Timeframe: The difference between Cobb angles measured prior to surgery and 2 years past surgery.

Population: 8 patients completed the study. Their pre-operative main curve measurements (Cobb angles) were measured and summarized. The same measurements were obtained at the 2 years follow up visits. The data was summarized and the means difference with the standard deviation were reported.

The difference between pre and post-operative Cobb angle measurements.

Outcome measures

Outcome measures
Measure
Anterior Vertebral Tethering
n=8 Participants
Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia. Anterior body tether (ABT): To insert the ABT in patients to correct AIS.
Cobb Angle in Degrees
22.37 degrees
Standard Deviation 4.16

Adverse Events

Anterior Vertebral Tethering

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Anterior Vertebral Tethering
n=8 participants at risk
Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia. Anterior body tether (ABT): To insert the ABT in patients to correct AIS.
Surgical and medical procedures
Broken Tether
100.0%
8/8 • Number of events 8 • 2 years

Additional Information

Suken Shah, MD, Orthopedics Department Chair

Nemours Hospital for Children

Phone: 3025472557

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place