Clinical Trial: Surgery, Pediatric Scoliosis

The Tether

Full Name

The Tether Vertebral Body Tethering System

Description

Purpose: To treat scoliosis in patients who have not yet met skeletal maturity.

For patients who have been diagnosed with scoliosis, the treatment options have been usually bracing or spinal fusion surgery. Bracing is the least invasive form of treatment. But it does is not always effective or tolerated by patients. The Tether device is a different surgical intervention, allowing the patient’s own bone growth to correct the curvature of the spine. Titanium screws are placed in the affected vertebrae and a flexible cord is anchored to the screws. The cord is then tightened to put pressure to slow the growth on one side of the spine and allowing the other side room to grow and level the vertebrae. Unlike fusion surgeries which are permanent, the Tether can be adjusted if the tension is too strong or too weak.

Since the surgery only requires several small incisions, recovery time is usually within several weeks. The physician may place limitations until patients are completely healed and will continue to monitor growth and curvature corrections.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

Skeletally immature individuals with idiopathic scoliosis

Failed bracing or intolerant of wearing a brace

To Participate: Please contact the Network Office of Research and Innovation at 610-402-9543.

For additional information:

This is a Humanitarian Use Device, which means that it is specially approved for idiopathic scoliosis. The surgeon will be able to provide additional information on this device.