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Anterior Vertebral Body Tethering
Anterior Vertebral Body Tethering for Scoliosis (FUTURE Trial)
N/A
Waitlist Available
Led By Firoz Miyanji
Research Sponsored by Spino Modulation Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Thoracic kyphosis (T5-T12) < 50°
Risser Stage 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
FUTURE Trial Summary
This trial will help researchers understand if the SCOLI-TETHER system is a safe and effective treatment for AIS.
Who is the study for?
This trial is for boys and girls over 8 years old with juvenile or adolescent idiopathic scoliosis. They should have a significant amount of growth left, a major thoracic curve between 40°-70°, and be mentally and physically able to follow the study's procedures. It's not for those with non-idiopathic scoliosis, abnormal neurological status, prior thoracic surgery, or bone diseases like osteoporosis.Check my eligibility
What is being tested?
The SCOLI-TETHER System is being tested as a fusionless treatment for young people with idiopathic scoliosis during their growth period. The study aims to determine how safe and effective this system is in straightening the spine without traditional surgical methods.See study design
What are the potential side effects?
While specific side effects are not listed here, similar spinal procedures may include risks such as pain at the site of surgery, infection risk from implants, possible injury to spinal nerves or cord leading to weakness or numbness, and potential need for additional surgeries.
FUTURE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spine curvature in the chest area is less than 50 degrees.
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My skeletal development is at an early stage.
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I have been diagnosed with scoliosis as a child or teenager.
FUTURE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cobb angle measurement
Rate of device- &/or procedure-related SAEs
FUTURE Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Vertebral Body Tethering surgery
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Who is running the clinical trial?
Spino Modulation Inc.Lead Sponsor
Firoz MiyanjiPrincipal InvestigatorBC Children's
1 Previous Clinical Trials
12 Total Patients Enrolled
Kevin SmitPrincipal InvestigatorCHEO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My spine curvature in the chest area is less than 50 degrees.My spine has a significant curve between 40° and 70°, or over 30° with unsuccessful brace treatment.I am willing and able to follow through with all required post-surgery visits and tests.My scoliosis curve is either under 30° or over 70°.I have been diagnosed with a bone condition such as osteoporosis or Paget's disease.My skeletal development is at an early stage.I am over 8 years old and still growing.My scoliosis is caused by a known condition.I cannot walk by myself.My doctor thinks this study might be risky or not good for me.I have had surgery in my chest area before.My upper back curve is 50 degrees or more.I have been diagnosed with scoliosis as a child or teenager.One of my spine bones is narrower than 20.5mm.I have abnormal neurological function.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for new participants to join this investigation?
"This investigation is not actively seeking participants at this time; it was posted on April 15th, 2019 and last updated February 3rd, 2022. Fortunately, there are 77 other trials that currently require potential candidates for enrollment."
Answered by AI
Do I qualify to partake in this research initiative?
"Eligibility for this clinical trial presumes a diagnosis of androgen-insensitivity syndrome, as well as being between the ages 9 to 18. A maximum of 51 patients will be admitted into the study."
Answered by AI
Does this clinical trial accommodate participants of advanced age?
"This clinical trial mandates that participants must be between 9 and 18 years old. 69 trials are available for minors, whereas 14 medical studies target individuals over 65 years of age"
Answered by AI
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