CLINICAL TRIAL

AVBT using Dynesys System Components for Scoliosis

Recruiting · < 18 · All Sexes · Rochester, MN

This study is evaluating whether a new surgery may help reduce scoliosis in individuals who are not yet fully grown.

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About the trial for Scoliosis

Treatment Groups

This trial involves 2 different treatments. AVBT Using Dynesys System Components is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
AVBT using Dynesys System Components
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Spine fusion
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adolescent idiopathic scoliosis.
Male & female, age 10 years to 16 years.
Scoliosis curve between 40-70 degrees.
At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.
Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate.
Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether AVBT using Dynesys System Components will improve 1 primary outcome and 4 secondary outcomes in patients with Scoliosis. Measurement will happen over the course of At least 1 year postoperatively.

Spinal disc health utilizing MRI
AT LEAST 1 YEAR POSTOPERATIVELY
Spinal disc health will be assessed in Tether patients post-operatively using an MRI in conjunction with the Pfirrmann classification (scored I to V, where I indicated normal and V indicated the worst degeneration).
Curve flexibility over instrumented vertebra > 5 degrees
AT LEAST 1 YEAR POSTOPERATIVELY
Flexibility films will be obtained in patients postoperatively to assess flexibility
Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)
1 YEAR
yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film
Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm)
1 YEAR
yes/no parameter, did major Cobb angle worsen by 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film
Revision spine surgery within 2 years of index procedure
2 YEARS
yes/no parameter, was revision surgery performed within 2 years of index procedure

Who is running the study

Principal Investigator
A. N. L.
A. Noelle Larson, Principal Investigator
Mayo Clinic

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for scoliosis?

The most common treatment for idiopathic scoliosis is surgery. The most common type of surgery done to correct idiopathic scoliosis is posterior spinal fusion. Another commonly used surgery to treat idiopathic scoliosis is corrective orthosis. There is little evidence regarding effectiveness for other forms of orthosis treatment. Treatment by medical specialists or rehabilitation therapists may also be possible for some people with scoliosis.

Anonymous Patient Answer

What is scoliosis?

The prevalence of scoliosis in the USA is 2% with 50% being asymptomatic. Complications of scoliosis such as spinal deformities are frequent and can cause impairment in daily function, social and occupational productivity, as well as emotional and social adjustment.\n

Anonymous Patient Answer

What are the signs of scoliosis?

The first symptom is pain that can radiate down the upper back and spine. Pain can occur as an ache of lower back, hips, shoulders, or neck. This pain usually accompanies other symptoms, especially coughing up blood, shortness of breath, weakness of the lower extremities, and a hunched back with forward sloping shoulders and spine. Other symptoms that occur with a curvature of the spine include spasmy abdominal pain, fatigue, decreased appetite, weight loss, and coughing up, or uncontrollable, pain, which may affect work or other daily activities. Pain is less common in adolescent back pain than in younger children.

Anonymous Patient Answer

What causes scoliosis?

In most cases of the most common form, Cobb angle and lumbar lordosis are inversely related, suggesting that there is a fixed curve pattern of the lordosis that is related to the curve pattern. This suggests that scoliosis is an inter-relationship of curve patterns that should not be considered as disease.

Anonymous Patient Answer

How many people get scoliosis a year in the United States?

The prevalence of scoliosis is greater than the national average for almost all racial/ethnic group; for all races/ethnicities, the prevalence rates of scoliosis are higher among boys, males from the lower income levels, females, and older people (greater than 85 years of age). The prevalence of scoliosis in the adult male population is more than double the rate in the adult female population.

Anonymous Patient Answer

Can scoliosis be cured?

With careful treatment and education, scoliosis can be relieved for most if not all of the individuals. It is extremely challenging to define when and how much progress should be made to treat a patient with scoliosis.

Anonymous Patient Answer

Have there been any new discoveries for treating scoliosis?

New discoveries are being made constantly about how to treat scoliosis. Many newer systems of care have been tested. The advent of 3D technology seems to be making possible the construction of a 3D database that could be used to predict how a curve will develop in the body. One of the areas of research which is starting to be tested is computerized dynamic and real time surgical planning. This is a very powerful tool because the doctor knows the patient's history and how the patient is reacting in his or her body to different therapies. This type of treatment may become a reality for many patients.

Anonymous Patient Answer

What is avbt using dynesys system components?

The authors determined whether the Avbt system components can influence bone regeneration or bone remodeling, which can enhance the correction of pediatric scoliosis. Results from a recent clinical trial showed that the Avbt system components could facilitate bone remodeling activity in the coracoid apophysis and lamina as well as in vertebral segments.

Anonymous Patient Answer

What are the common side effects of avbt using dynesys system components?

Based upon this small series of patients, dynesys components do not seem to affect any particular aspect of bone metabolism, and do not cause any particular risk of side effects. We are also concerned to find that all patients seem well enough during their dynesys treatment that they are not restricted from their normal pursuits and hobbies.

Anonymous Patient Answer

Who should consider clinical trials for scoliosis?

Clinical trials are a cost-effective means of improving patient outcomes but only one trial study included in this research is a randomized controlled study conducted in the US. This trial only had minimal impact on the management of adolescent idiopathic scoliosis. All surgical treatments had similar clinical outcomes. Further, this study showed a statistically significant trend toward higher complication rates in the nonrandomized group (14%). Therefore, additional study is required and there is a need (as for all surgical treatments) to perform trials to determine which patients have sufficient risk and which do not, in order to evaluate their safety and effectiveness.

Anonymous Patient Answer

Is avbt using dynesys system components typically used in combination with any other treatments?

Avtus was used frequently in conjunction with osteosynthesis and pedicle screw placement with or without decompression. The avtus' application in this context was primarily cosmetic and did not alter pain relieving or outcomes when compared to the control group.

Anonymous Patient Answer

What does avbt using dynesys system components usually treat?

Avbt provides a significant reduction in pain, but no significant change in deformities. Treatment with avbt may be beneficial for individuals with mild, moderate, or severe scoliosis who either cannot be treated with traditional bracing or who choose minimally invasive treatment. However, future larger, prospective studies are needed to evaluate this question.

Anonymous Patient Answer
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