Spinal Tethering for Scoliosis

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen by Ron El-Hawary, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Pediatric Spine Foundation

Disqualifiers: Infections, Prior spinal surgery, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is anterior vertebral body tethering (AVBT) safe for humans?

Studies on anterior vertebral body tethering (AVBT) for scoliosis show that it has some risks, with about 3.3% of patients experiencing major complications like fluid buildup in the chest or nerve issues, and another 3.3% having minor issues like nausea or wound infections. However, no patients needed blood transfusions, and most complications were manageable.

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How is the treatment Anterior Vertebral Body Tethering (AVBT) for scoliosis different from other treatments?

Anterior Vertebral Body Tethering (AVBT) is unique because it corrects scoliosis without the need for spinal fusion, allowing for continued growth and flexibility in the spine. Unlike traditional methods that involve fusing the spine, AVBT uses a flexible cord to guide the spine's growth, making it a promising option for children who are still growing.

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Eligibility Criteria

This trial is for skeletally immature children with idiopathic scoliosis who have a major Cobb angle between 30° and 65°, have not had prior spinal surgery at the levels to be treated, and are unable to use bracing. They must also be able to return for follow-up visits and agree to participate in study procedures.

Inclusion Criteria

Bracing did not work or caused me issues.

My bones are strong enough for screw fixation.

I have been diagnosed with idiopathic scoliosis.

Exclusion Criteria

I have a condition that makes spinal surgery not beneficial for me.

I have an infection or skin issue at the surgery area.

Evidence of poor bone quality

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo anterior vertebral body tethering surgery

Surgery and immediate recovery

Follow-up

Participants are monitored for complications and spine growth outcomes

5 years

Participant Groups

The trial studies Anterior Vertebral Body Tethering (AVBT), a new minimally invasive technique for controlling spine curve progression in children with scoliosis. It will compare long-term outcomes of AVBT patients with normal controls regarding spine growth and maintenance of curvature.

Group I: Anterior Vertebral Body Tethering Experimental Treatment 1 Intervention

The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete.

Anterior Vertebral Body Tethering is already approved in United States for the following indications:

🇺🇸 Approved in United States as The Tether - Vertebral Body Tethering System for:

• Progressive idiopathic scoliosis in skeletally immature patients with a major Cobb angle of 30 to 65 degrees

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vanderbilt University Nashville, TN

Shriners Children's Chicago Chicago, IL

Shriners Children's Portland Portland, OR

Children's National Hospital Washington, United States

More Trial Locations

Who Is Running the Clinical Trial?

Pediatric Spine Foundation Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Anterior Spinal Growth Modulation in Skeletally Immature Patients with Idiopathic Scoliosis: A Comparison with Posterior Spinal Fusion at 2 to 5 Years Postoperatively. [2023] Anterior vertebral body tethering (AVBT) has been introduced as a means of correcting scoliosis without fusion. The purpose of this study was to compare outcomes for patients with thoracic idiopathic scoliosis between a group of patients who underwent AVBT and a matched cohort of patients treated with posterior spinal fusion and instrumentation (PSF).

2. United States pubmed.ncbi.nlm.nih.gov

Anterior Vertebral Body Tethering Compared with Posterior Spinal Fusion for Major Thoracic Curves: A Retrospective Comparison by the Harms Study Group. [2023] Anterior vertebral body tethering (AVBT) is an alternative to posterior spinal fusion (PSF) for the surgical treatment of scoliosis. The present study utilized a large, multicenter database and propensity matching to compare outcomes of AVBT to PSF in patients with idiopathic scoliosis.

3. United States pubmed.ncbi.nlm.nih.gov

Prospective Follow-up Report on Anterior Vertebral Body Tethering for Idiopathic Scoliosis: Interim Results from an FDA IDE Study. [2021] Anterior vertebral body tethering (aVBT) has emerged as a novel treatment option for patients with idiopathic scoliosis. We present the results from the first U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study on aVBT.

4. England pubmed.ncbi.nlm.nih.gov

Risk of early complication following anterior vertebral body tethering for idiopathic scoliosis. [2021] The purpose of this study was to determine peri-operative morbidity associated with anterior vertebral body tethering (aVBT) for idiopathic scoliosis.

5. England pubmed.ncbi.nlm.nih.gov

Early operative morbidity in 184 cases of anterior vertebral body tethering. [2022] Fusion is the current standard of care for AIS. Anterior vertebral body tethering (AVBT) is a motion-sparing alternative gaining interest. As a novel procedure, there is a paucity of literature on safety. Here, we report 90-day complication rates in 184 patients who underwent AVBT by a single surgeon. Patients were retrospectively reviewed. Approaches included 71 thoracic, 45 thoracolumbar, 68 double. Major complications were those requiring readmittance or reoperation, prolonged use of invasive materials such as chest tubes, or resulted in spinal cord or nerve root injury. Minor complications resolved without invasive intervention. Mean operative time and blood loss were 186.5 ± 60.3 min and 167.2 ± 105.0 ml, respectively. No patient required allogenic blood transfusion. 6 patients experienced major (3.3%), and 6 had minor complications (3.3%). Major complications included 3 chylothoracies, 2 hemothoracies, and 1 lumbar radiculopathy secondary to screw placement requiring re-operation. Minor complications included 1 patient with respiratory distress requiring supplementary oxygen, 1 superficial wound infection, 2 cases of prolonged nausea, and 1 Raynaud phenomenon. In 184 patients who underwent AVBT for AIS, major and minor complication rates were both 3.3%.

6. United States pubmed.ncbi.nlm.nih.gov

Thoracoscopic Vertebral Body Tethering for Adolescent Idiopathic Scoliosis: A Minimum of 2 Years' Results of 21 Patients. [2021] Anterior vertebral body tethering (VBT) is a growth modulating and fusionless treatment option that is considered as a new promising method for the management of adolescent idiopathic scoliosis (AIS). This prospective cohort study aimed to present the minimum 2-year results of anterior VBT applied to 21 skeletally immature patients with AIS.

7. United States pubmed.ncbi.nlm.nih.gov

Anterior Vertebral Body Tethering for Adolescent Scoliosis with Growth Remaining: A Retrospective Review of 2 to 5-Year Postoperative Results. [2021] Anterior vertebral body tethering (VBT) is an early treatment option for progressive scoliosis in pediatric patients, allowing for continued deformity correction during normal growth. We report postoperative radiographic and clinical outcomes for patients treated with VBT.

8. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of Anterior Vertebral Body Tethering in Skeletally Mature Children with Adolescent Idiopathic Scoliosis: A Preliminary Report. [2021] Anterior vertebral body tethering (AVBT) offers a dynamic fusionless correction option for children with adolescent idiopathic scoliosis (AIS). Few existing clinical studies evaluating novel AVBT in skeletally immature children have questioned the midterm efficacy with concerns of overcorrection and curve progression with remaining growth. The current study investigates the effect of this technique in skeletally mature children (Risser ≥ 4 and Sanders ≥ 7) with AIS with limited remaining growth potential.