A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
This study is investigating a new treatment for scoliosis in growing children called Anterior Vertebral Body Tethering (AVBT). Scoliosis is a condition where the spine curves sideways. AVBT is a less invasive surgery than traditional spinal fusion. The treatment works by gently guiding the spine to grow straighter. Researchers want to understand the long-term effects of AVBT. They will look at how the spine grows in 3D, how well the treatment keeps the curve under control over time, and any problems that might come up during or after the procedure. This will help doctors understand if AVBT is a good alternative to other treatments for young people with scoliosis.
At a glance
What is this study about?
Scoliosis is a condition where your spine develops a curve, often appearing in children and teenagers. For some, this curve can get worse, and doctors might recommend treatments to stop it from progressing. One traditional treatment is spinal fusion surgery, which stiffens part of the spine. However, a newer, less invasive option called Anterior Vertebral Body Tethering (AVBT) has become available.
AVBT works differently. Instead of fusing the spine, small screws are placed into the curved vertebrae (the bones of your spine) and connected with a flexible cord, or 'tether.' This tether gently pulls on the outside of the curve. As you grow, the tether helps guide the spine to grow straighter, as if you were wearing internal braces. This study is important because AVBT is still quite new, and doctors want to understand how it performs over many years.
The main goals of this study are to see how children's spines grow after AVBT compared to children without scoliosis, to check if the treatment successfully keeps the spine's curve from getting too big by the time they stop growing, and to keep track of any side effects or problems with the procedure or the tether itself. This information will help doctors understand who might benefit most from AVBT and what to expect in the long term.
Key takeaways
- This study evaluates a new scoliosis treatment called AVBT.
- It focuses on spine growth and curve correction in growing children.
- Researchers want to understand long-term results and potential complications.
- Participants must have idiopathic scoliosis and be scheduled for AVBT.
- It helps contribute to better care for young people with scoliosis in the future.
Who may be eligible?
This study is looking for young patients who have a specific type of scoliosis called 'idiopathic scoliosis,' which means the cause isn't known. To be considered, you must still be growing (meaning your bones haven't fully matured yet) and your doctor must be planning for you to have the AVBT surgery.
Your spine curve needs to be significant enough to warrant treatment, specifically between 30 and 65 degrees. Also, your bones need to be strong enough and shaped correctly to hold the special screws used in the surgery. You would also need to have tried and not been able to continue with or tolerate bracing, which is another common treatment for scoliosis.
There are also some reasons why you might not be able to join the study. For example, if you have an infection, have had spinal surgery before at the same part of your spine, or have very weak bones. Other medical conditions or if you are unable to attend follow-up appointments would also mean you couldn't take part. You also need to be able to understand and sign the consent form.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I have idiopathic scoliosis (the cause is unknown).
- My doctor says I need AVBT surgery.
- I am still growing (not finished growing yet).
- My spine curve is considered significant by my doctor (between 30 and 65 degrees).
- I have tried bracing for my scoliosis but it didn't work for me or I couldn't tolerate it.
- I don't have any current infections or other serious health problems that would prevent surgery.
What does participation involve?
The study aims to gather information over a long period after your AVBT surgery. You will likely have regular check-ups with your doctor, which will include taking X-rays to see how your spine is growing and how well the tether is working. These appointments will help the research team understand the long-term effects of the treatment and track any changes in your spine's curve or growth. The exact number and timing of these visits will be explained by the study team, but they are important for monitoring your progress and ensuring the study collects all the necessary information.
Potential risks and benefits
Locations (12)
- Children's National HospitalVerified postcodeWashington D.C., United States· Recruiting
- Shriners Children's ChicagoVerified postcodeChicago, United States· Recruiting
- Gillette Children's Specialty HealthcareVerified postcodeSaint Paul, United States· Recruiting
- Washington UniversityVerified postcodeSt Louis, United States· Recruiting
- Morgan Stanley Childrens Hospital of New York-PresbyterianVerified postcodeNew York, United States· Recruiting
- Cincinnati Children's Hospital Medical CenterVerified postcodeCincinnati, United States· Recruiting
- Shriners Children's PortlandVerified postcodePortland, United States· Recruiting
- Children's Hospital of PhiladelphiaVerified postcodePhiladelphia, United States· Recruiting
- The Medical University of South CarolinaVerified postcodeCharleston, United States· Recruiting
- Vanderbilt UniversityVerified postcodeNashville, United States· Recruiting
- Primary Children's HospitalVerified postcodeSalt Lake City, United States· Recruiting
- Children's Hospital of Eastern OntarioVerified postcodeOttawa, Canada· Recruiting
Common questions
What is scoliosis?
Scoliosis is a condition where your spine curves sideways, often developing in children and teenagers.
What is AVBT surgery?
AVBT (Anterior Vertebral Body Tethering) is a newer surgery for scoliosis. It uses a flexible cord to gently guide your spine to grow straighter.
Who is this study for?
This study is for young people with idiopathic scoliosis who are still growing and are planning to have AVBT surgery.
Will I have more doctor visits if I join?
Yes, you will have regular follow-up appointments and X-rays to check your spine's growth and the treatment's success over time.
What are the main goals of the study?
The study aims to understand how AVBT affects spine growth, how well it keeps the curve stable long-term, and any potential problems.
How to find out more
Tyler Farber
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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