Status: The Wallis Stabilization Trial has now been completed.
Desert Institute for Spine Care has been selected to participate in the Wallis Stabilization System Clinical Trial.
Introduction to the Wallis Stabilization System The Wallis Normalization System is a non-fusion, spinal stabilization device that is currently limited by US law to investigational use within the US. The Wallis clinical study is a multi-center, prospective, randomized study comparing the safety and effectiveness of the Wallis device to the latest non-surgical treatment regimen including medication, physical therapy, and spinal injections. The Wallis System is designed to help with the pain caused by degenerative disc disease (DDD) by stabilizing the lumbar spine without a fusion procedure.
The primary objective of the Wallis Clinical Study is to demonstrate that the Wallis System is superior to non-surgical care at treating mild to moderate degenerative disc disease at one or two levels between L1 and L5 of the lumbar spine.
Approximately 20 medical centers will be enrolling patients into this clinical study to assess the safety and effectiveness of the Wallis System for mild to moderate degenerative disc disease of the lumbar spine.
The Study will be randomized so that 67% of the study participants will receive a Wallis Device and 33% will receive non-surgical, conservative care treatment which will consist of a balance between medication, physical therapy, and spinal therapy injections. Patients will be randomly assigned to receive either a Wallis Device or conservative care.
Austin, TX-based Abbott Spine is a wholly-owned subsidiary of Abbott Laboratories. The company researches, develops, and sells spinal instrumentation in the treatment of degenerative spinal disorders.