K2M Mesa versus Small Stature Systems in Degenerative Lumbar Spondylolisthesis: A Noninferiority, Two Years Followup Trial

Abstract

Objectives: To assess the no inferiority of K2M Mesa Small Stature versus K2M Mesa System for degenerative lumbar spondylolisthesis (DS). To assess pros and cons of K2M Mesa Small Stature System vs K2M Mesa System to treat degenerative lumbar spondylolisthesis. To assess evolutions of symptoms after surgery using a lower profile screws and rods system for lumbar arthrodesis generally adopted in pediatric patients. Methods: Seventy-one (71) patients were evaluated during a 24 months follow-up period. Oswestry Disability Index (ODI) plus Economic and Functional PROLO grades and VAS scores were obtained using a webbased questionnaire. We investigated ODI plus Economic and Functional PROLO grades and VAS scores on a series of patients treated surgically for degenerative lumbar spondylolisthesis with a 24 months follow-up. 40 patients were treated with K2M Mesa Small Stature System and 31 patients with K2M Mesa System. All surgical operation were performed by the same surgeon (SM) using CT based computer assisted surgical navigation. No statistical difference was noticed among the two groups. K2M Mesa Small Stature System is lower in profile and size than standard Mesa system. Nevertheless it provided comparable follow-up results to K2M Mesa. Results: Variables studied at 6, 12 and 24 months were similar among two groups (p>0,05). Conclusions: Lower profile, lower invasivity Mesa Small Stature System demonstrated safe and reliable for degenerative lumbar spine disease