Abstract
Purpose of study
This RCT is to determine whether or not there is a clinical benefit from inserting a dynamic stabilising implant such as the Wallis ligament on the functional recovery of patients who have undergone lumbar decompression surgery. This Interspinous implant was developed as an anatomically conserving procedure without recourse to lumbar spinal fusion surgery. The biomechanical studies have shown that unloading the disc and facet joints reduces intradiscal pressures at same and adjacent levels. The aim of this study was to identify a patential Wallis affect.
Methods
Ethicallly approved. Patients were randomized into 2 groups, decompression alone or decompression with wallis interspinous ligament stabilisation. Patients were assessed pre operatively and post operatively every 6 months by VAS pain score and Oswestry Disability Index.
Summary of findings
A total of 60 patients were recriuted the study from October 2005. Equal number had been randomized into two groups. The mean age of 54 (24–85) and the average follow is 36 months (6–48). The results were significantly better in decompression plus Wallis group compared to decompression alone, showing a minimal clinical difference compared to the control group.
Relationship between findings and existing knowledge: Our results deomonstrate that clincial outcomes are significantly better when a Wallis implant was used in lumbar deompression. Patients experienced less back pain.
Overall significance of findings: The Wallis implant represents a successful non fusion stabilisation device in the treatment of degenerative lumbar spine disease with canal stenosis. Minimal soft tissue dissection, quick rehabilitation, low morbidity. The Wallis ligament sucessfully treats spinal stenosis by reducing pain score, preserving mobility, and function.
