The USA's Food and Drug Administration (FDA) recently announced that it had approved its very first spinal tethering device for correcting idiopathic scoliosis in children and adolescents.
The Tether™ vertebral body tethering system is designed to help correct spinal curvatures in young patients whose bones have yet to fully mature.
Made up of titanium anchors, bone screws and set screws, along with a flexible polymer cord, the device aims to prevent further curve progression, theoretically eliminating the need for spinal fusion surgery.
What does this mean for young scoliosis patients in the USA?
Manufactured by Zimmer Biomet, the spinal tether device has been presented as something of a breakthrough in paediatric scoliosis management. It is an innovative treatment option that aims to improve quality of life for young patients with idiopathic scoliosis.
Dr Baron Lonner, Professor of Orthopaedic Surgery at New York City's Mount Sinai Hospital, applauded the FDA's decision, noting that vertebral body tethering (VBT) could become a "mainstream option for scoliosis treatment" in due course.
The Tether™ VBT system is designed to help young scoliosis patients with a Cobb angle of 30-65 degrees.
Idiopathic scoliosis in children
Idiopathic scoliosis is the most common form of scoliosis. The causes of idiopathic scoliosis are unknown (this is what the word 'idiopathic' means). It is typically diagnosed in children and adolescents between the ages of 10 and 18.
The most commonly-prescribed medical treatment for idiopathic scoliosis is bracing. If the brace does not successfully halt the progression of the patient's spinal curve, surgery may be recommended.
Though often effective, the spinal fusion procedure can lead to problems of its own, with patients sometimes facing such issues as restricted motion and arthritis down the line.
The FDA's decision to approve this new tethering device could give young scoliosis sufferers a new hope in tackling their spinal issues.
Is vertebral body tethering effective?
In June 2018, NHS England published a report titled Evidence Review: Vertebral Body Tethering for Treatment of Idiopathic Scoliosis.
This review examined the effectiveness of VBT and the complication rates associated with this treatment method.
Here are two key findings from NHS England's report...
- 5 out of 25 patients required repeat surgery: "At skeletal maturity, Ames, Samdami et al reported 5 patients from the cohort of 25 requiring repeat surgery to loosen the tether in order to treat or prevent overcorrection (Ames, Samdani, & Betz, 2016)."
- In total, 44% of patients experienced some complications. In addition to the 5 patients who required repeat surgery (see above), another 5 experienced "transient thigh pain or numbness", and there was 1 patient with "unresolved intercostal neuralgia".
- There's not yet enough evidence of VBT's effectiveness: "It is not possible at present, given the lack of experimental studies, to confirm that this treatment is relatively effective, safe and acceptable when compared to standard care."
Scoliosis treatment at the Scoliosis SOS Clinic
While the FDA's decision may be welcome news to young scoliosis sufferers in the USA, vertebral body tethering still has a long way to go as an alternative to spinal fusion surgery, and it remains to be seen just how effective the Tether™ will be in the long term. Note also that this treatment method still requires the patient to undergo an operation.
If you're seeking a less invasive option for yourself or a loved one with scoliosis, you may be interested in the treatment courses that we deliver here at the Scoliosis SOS Clinic in London, England. Our ScolioGold programme combines a variety of non-surgical methods to create a unique approach that is unlike anything offered elsewhere.
Better still, the ScolioGold method is constantly evolving in line with advances in the field of non-surgical treatment, ensuring that our therapeutic programme continues to deliver the best possible results.
Contact Scoliosis SOS to book a ScolioGold consultation >>