For children and adolescent patients with the most common form of scoliosis, called idiopathic scoliosis, which does not respond favourably to bracing, treatment options have been limited to fusion surgeries.
However, Mr Jason Bernard, Consultant Orthopaedic Spinal Surgeon at Wimbledon Clinics, has been successfully performing revolutionary scoliosis treatment, Vertebral Body Tethering (VBT). In this blog, he discusses the benefits of the procedure over fusion surgeries and what the FDA’s approval might mean for patient access to VBT.
The U.S. Food and Drug Administration’s approval of the first spinal tether device, to correct idiopathic scoliosis, is welcome news.
The device, called The Tether – Vertebral Body Tethering System – is intended to treat growing children and adolescents whose spinal curves are approaching or have reached the range where surgical treatment is an option.
For patients in the UK, surgical treatment on the NHS to correct the spinal deformity typically means having spinal fusion surgery. This involves metal implants being attached to the spine, and then connected to a single rod or two rods. Implants are used to correct the spine and hold the spine in the corrected position until the instrumented segments fuse as one bone.
Spinal fusion is an invasive surgical procedure which has a lengthy recovery time (3-6 months) and limits patients’ spinal flexibility, preventing them from taking part in certain activities such as gymnastics.
VBT represents a paradigm change in how adolescent idiopathic scoliosis (AIS) can be treated. I’ll come on to how and why shortly.
How many patients does this affect?
Around two or three people in every 100 have scoliosis, according to the UK National Screening Committee (UK NSC). Around 1:1000 are bad enough to need surgery.
Idiopathic scoliosis is a sideways curvature of the spine, the cause of which is unknown. It is the most common spinal deformity in children and is most often diagnosed between ages 10 to 18, although it may occur at a younger age.
In general, AIS curves progress during the rapid growth period of the patient. While most curves slow their progression significantly at the time of skeletal maturity, some, especially curves greater than 50°, continue to progress during adulthood.
Patients with AIS typically have no severe pain (although it’s common to have some lower back or right shoulder pain) or neurologic abnormalities. They will often display visible symptoms – a rib prominence or “hump”, shoulder height asymmetry or a torso “lean”, or waist asymmetry.
Following diagnosis, AIS is typically treated with simple observation or a scoliosis brace, to try and halt or slow progression of the curve – with an ultimate goal of avoiding a spinal fusion surgery.
While spinal fusion is successful, this surgery permanently restricts the motion of the spine and may have long-term complications such as pain, arthritis and future spinal deformities, which could require additional surgical treatment.
VBT provides a ‘glimpse of a cure’
The FDA’s approval of The Tether should increase awareness of the treatment. From having successfully performed VBT on various patients, I have seen first-hand that keyhole surgery means less scarring and quicker recovery times, and patients retain greater mobility.
The FDA reviewed clinical data supporting the safety and probable benefit of The Tether - Vertebral Body Tethering System from 57 patients who received the device. At two years, 43 patients had sufficient improvement of the curvature of their spines and did not need spinal fusion.
At Wimbledon Clinics, we have followed up with patients for up to four years – we’re the only practice in Europe that extends the aftercare for this long. And it is our intention to provide long-term review and support to all of our VBT patients. Satisfaction is high and re-operation rates are very low.
VBT provides us with the first glimpse of a ‘cure’ for AIS. Over time, the tether slows growth on the curved side of the spine and promotes growth on the opposite side. This provides additional correction of the curve as the patient continues to grow.
As the first practice to perform VBT, we’ve seen just how transformative the operation has been for AIS patients. While we might still be a little way from NICE introducing it on the NHS, the FDA’s approval should help patients access this effective non-fusion treatment for AIS.
Mr Jason Bernard
Consultant Orthopaedic Spinal Surgeon
Jason treats a wide range of spinal diseases and back injuries – from simple disc problems to complex cancer and scoliosis surgeries. He has extensive expertise in the revolutionary scoliosis treatment, Vertebral Body Tethering (VBT).