Additional findings at the six-month juncture from Intralink-Spine’s early safety and feasibility study of the Réjuve system have indicated that the device can effectively eliminates or reduces low back pain.
“We have demonstrated the safety of this device, and it has performed as expected. The dramatic pain reduction in these patients correlated with some objective measures: there was an average increase in lumbar range of motion of nine degrees and there was a statistically significant 25% increase in treated level lordosis, based on kinematic data analysis performed by Medical Metrics Inc. Decreased lumbar lordosis is known to be related to disc degeneration and back pain, especially when standing,” states Tom Hedman, the inventor of the system and adjunct associate professor in the F Joseph Halcomb III Department of Biomedical Engineering at the University of Kentucky.
“I was also excited to see that the only symptomatic disc in these first few low back pain patients that was shown to be clinically unstable pre-treatment (QSI=2.5, meaning the instability as quantified by translation per degree of rotation (TPDR) was 2.5 standard deviations above the mean for an asymptomatic, radiographically normal population) was effectively stabilised by the Réjuve treatment. This previously symptomatic and unstable segment was asymptomatic (no pain and no disability at one month through six months) and stable with a normal TPDR (QSI=-0.1). This result illustrates and affirms one of the mechanisms for pain relief associated with this product,” says Hedman.