SPINE CLINICAL STUDIES
COMBINED MAGNETIC FIELDS ACCELERATE AND INCREASE SPINE FUSION: A DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY LINOVITZ RJ, PATHRIA M, BERNHARDT M, GREEN D, LAW MD, MCGUIRE RA, MONTESANO PX, RECHTINE G, SALIB RM, RYABY JT, FADEN JS, PONDER R, MUENZ LR, MAGEE FP, GARFIN SA SUMMARY: This investigational, randomized controlled study examines the safety and effectiveness of the DJO ® Spinalogic ® as an adjunct treatment to aid patients that underwent primary lumbar fusion surgery at one or two levels without instrumentation. Patients received autograft alone or in combination with allograft. Overall, 201 patients were available for evaluation, with radiographic fusion determined by panel blinded to treatment group (active vs. sham device) Adjunctive use of the DJO Spinalogic device significantly increased lumbar fusion from 43% to 64% (p=.001) at the 9 months follow up. The generalized estimating equations model indicated successful radiographic spinal fusion and showed a significant acceleration of the healing process (p=0.0024). The study showed that the Spinalogic device can accelerate the healing process. The IDE study supported PMA approval for the Spinalogic indication of primary lumbar fusion at one or two levels. In conclusion, adjuvant use of Spinalogic was statistically beneficial in the overall patient population.
“ THE DJO ® SPINALOGIC ® SIGNIFICANTLY INCREASED LUMBAR FUSION ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/12131732/
17
Made with FlippingBook - PDF hosting