Spinal Tethering for Scoliosis

Recruiting at 13 trial locations

Overseen By Tyler Farber

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Pediatric Spine Foundation

Disqualifiers: Infections, Prior spinal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate recovery

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new surgery, anterior vertebral body tethering (AVBT), for children with scoliosis, a condition where the spine curves sideways. The researchers seek to determine if AVBT can prevent the spine's curve from worsening and to identify any complications. This surgery may be suitable for children with scoliosis who are still growing and have not had success with back braces. As an unphased trial, this study provides a unique opportunity for patients to contribute to pioneering research that could lead to new treatment options for scoliosis.

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.

What prior data suggests that this technique is safe for skeletally immature children with scoliosis?

Research has shown that anterior vertebral body tethering (AVBT) is generally well-tolerated in young patients with scoliosis. Studies have found that AVBT effectively corrects the spine's curve and maintains a reasonable rate of complications. Specifically, one study noted that AVBT provides promising results in correcting the spine while keeping complications at an acceptable level for patients with idiopathic scoliosis, a type of scoliosis with no known cause.

The FDA has approved this technique under a Humanitarian Device Exemption, indicating that its benefits outweigh the risks for the specific group it targets. However, concerns exist about the possibility of overcorrection or the curve worsening as children grow. Overall, the procedure appears safe, but like any surgery, it carries potential risks that should be considered. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for scoliosis, which typically include bracing or spinal fusion surgery, anterior vertebral body tethering is a less invasive surgery that preserves more of the spine's natural flexibility. This technique uses a flexible cord to tether the spine, allowing for guided growth and gradual correction as the child grows. Researchers are excited because it offers a motion-preserving alternative that could reduce the need for more invasive procedures, potentially leading to faster recovery times and improved quality of life for patients.

What evidence suggests that anterior vertebral body tethering is effective for scoliosis?

Research has shown that Anterior Vertebral Body Tethering (AVBT), the treatment under study in this trial, effectively treats adolescent idiopathic scoliosis (AIS). Studies have found that AVBT can successfully correct spine curves by applying pressure on one side of the spine, allowing the other side to grow straighter. Patients undergoing AVBT often spend less time in the hospital and require fewer spinal segments treated compared to traditional methods. Despite a 22% chance of complications, the procedure shows promise in managing spine curvature. Researchers continue to study the long-term effects to confirm these benefits over time. ^{4 5 6 7 8}

Who Is on the Research Team?

Ron El-Hawary, MD

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Anterior Vertebral Body Tethering

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Pediatric Spine Foundation

Lead Sponsor

Trials

2

Recruited

320+

Published Research Related to This Trial

In a study of 29 pediatric patients treated with anterior vertebral body tethering (VBT) for scoliosis, 74% achieved successful outcomes with a curve magnitude of ≤30°, demonstrating VBT's efficacy in managing progressive scoliosis during growth.

The procedure had a low revision rate of 21%, and 93% of patients avoided the need for posterior spinal fusion, suggesting that VBT is a reliable treatment option for adolescent scoliosis in skeletally immature individuals.

NCBI (Pubmed)

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. Hoernschemeyer, DG., Boeyer, ME., Robertson, ME., et al.[2021]

In a study of 10 skeletally mature girls with adolescent idiopathic scoliosis (AIS), the anterior vertebral body tethering (AVBT) technique significantly reduced the mean Cobb angle from 52.0° to 15.3° after one year, indicating effective curve correction without fusion.

Patients reported improved quality of life, as shown by an increase in Scoliosis Research Society-22 (SRS-22) scores from 78.0 to 92.5, and no complications were observed during the follow-up period, suggesting the safety of the AVBT technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Anterior Vertebral Body Tethering in Skeletally Mature Children with Adolescent Idiopathic Scoliosis: A Preliminary Report. Hegde, SK., Venkatesan, M., Akbari, KK., et al.[2021]

In a study comparing 23 patients who underwent anterior vertebral body tethering (AVBT) and 26 patients treated with posterior spinal fusion (PSF) for idiopathic scoliosis, the PSF group showed significantly better long-term correction of spinal deformity, with a mean thoracic curve of 16° compared to 33° in the AVBT group after an average follow-up of 3.4 years.

AVBT resulted in a higher rate of revision procedures (9 in the AVBT group, including 3 conversions to PSF) and a notable incidence of broken tethers (52%), indicating potential challenges in maintaining correction compared to PSF, although patient-reported outcomes were similar between both groups.

NCBI (Pubmed)

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. Newton, PO., Bartley, CE., Bastrom, TP., et al.[2023]

In a study of 21 skeletally immature patients with adolescent idiopathic scoliosis (AIS), anterior vertebral body tethering (VBT) demonstrated significant improvement in spinal curvature, reducing average major thoracic curve magnitudes from 48.2 degrees preoperatively to 10 degrees at the last follow-up after an average of 27.4 months (P<0.001).

The procedure was found to be safe, with only one case of chylothorax and one case of tether breakage reported, indicating that VBT is an effective and low-complication option for managing AIS while preserving spinal motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracoscopic Vertebral Body Tethering for Adolescent Idiopathic Scoliosis: A Minimum of 2 Years' Results of 21 Patients. Pehlivanoglu, T., Oltulu, I., Ofluoglu, E., et al.[2021]

In a study comparing anterior vertebral body tethering (AVBT) to posterior spinal fusion (PSF) in 237 patients with idiopathic scoliosis, AVBT resulted in a higher percentage of patients (76%) having a thoracic curve of less than 35° at follow-up compared to 97.4% in the PSF group, indicating that PSF may provide better long-term curve correction.

However, 16% of AVBT patients required subsequent surgical procedures, including conversions to PSF, compared to only 1.3% in the PSF group, suggesting that while AVBT can be effective, it may also lead to more complications requiring additional surgeries.

NCBI (Pubmed)

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. Newton, PO., Parent, S., Miyanji, F., et al.[2023]

In a study of 184 patients undergoing Anterior Vertebral Body Tethering (AVBT) for Adolescent Idiopathic Scoliosis (AIS), the overall complication rate was low, with both major and minor complications occurring in 3.3% of patients.

Major complications included chylothoracies and hemothoracies, while minor complications were generally mild and resolved without invasive treatment, indicating that AVBT is a relatively safe motion-sparing alternative to traditional spinal fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early operative morbidity in 184 cases of anterior vertebral body tethering. Meyers, J., Eaker, L., von Treuheim, TDP., et al.[2022]

The study involved 57 skeletally immature patients with idiopathic scoliosis, showing that anterior vertebral body tethering (aVBT) significantly corrected the main thoracic Cobb angle from an average of 40.4° to 18.7° after an average follow-up of 55.2 months, indicating its efficacy in treating scoliosis.

No major complications were reported, affirming the safety of aVBT, although 12.3% of patients required revision surgeries, highlighting a need for further refinement in the technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Follow-up Report on Anterior Vertebral Body Tethering for Idiopathic Scoliosis: Interim Results from an FDA IDE Study. Samdani, AF., Pahys, JM., Ames, RJ., et al.[2021]

In a study of 120 patients who underwent anterior vertebral body tethering (aVBT) for idiopathic scoliosis, the procedure showed significant immediate post-operative improvement in scoliosis, reducing the curvature from an average of 51.2° to 26.9° (p < 0.05).

However, the study reported a 15.8% overall complication rate and a 6.7% rate of unplanned return to the operating room (UPROR) at 2 years post-operation, indicating that while aVBT can be effective, it also carries notable risks, particularly during the early learning curve of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of early complication following anterior vertebral body tethering for idiopathic scoliosis. Abdullah, A., Parent, S., Miyanji, F., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8500278/

Anterior Vertebral Body Tethering for Treatment of ... AVBT led to satisfactory deformity correction with a 22% complication rate. Long-term follow up is necessary until we can understand the true value of this ...

2. ijssurgery.com ijssurgery.com/content/15/5/995

Efficacy of Anterior Vertebral Body Tethering in Skeletally ... Anterior vertebral body tethering (AVBT) is a novel, dynamic nonfusion growth modulation technique developed to treat adolescent idiopathic scoliosis (AIS).

3. journals.lww.com journals.lww.com/clinorthop/fulltext/9900/how_does_anterior_vertebral_body_tethering_compare.2059.aspx

How Does Anterior Vertebral Body Tethering Compare to... Intraoperative data revealed that AVBT resulted in a shorter length of stay (2 ± 1 versus 3 ± 1 days; p = 0.02) and fewer levels instrumented (7 ...

4. stlouischildrens.org stlouischildrens.org/health-resources/pulse/pros-and-cons-vertebral-body-tethering-scoliosis

The Pros and Cons of Vertebral Body Tethering for Scoliosis This technique places a compressive force over the convex side of the spine (slowing down growth) to permit the concave side of the spine to relatively grow ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0296739

Predicting radiographic outcomes of vertebral body tethering ... This study aimed to develop a machine learning-based tool to predict short- and midterm spinal curve correction in AIS patients who underwent AVBT surgery.

6. fda.gov fda.gov/media/187213/download?attachment

Vertebral Body Tethering System (H190005) The Tether™ – Vertebral Body Tethering System is indicated for skeletally immature patients that require surgical treatment to obtain and maintain correction of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33249889/

Safety and efficacy of anterior vertebral body tethering in ... AVBT is associated with satisfactory correction of deformity and an acceptable complication rate when used in skeletally immature patients with idiopathic ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03506334?cond=tethering%20scoliosis&viewType=Table&rank=4

Anterior Vertebral Body Tethering (AVBT) Using Zimmer ... The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe ...