Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol.

Abstract

The study aims to demonstrate non-inferior clinical success (safety and efficacy) of the MOTUS Total Joint Replacement device relative to posterior or transforaminal lumbar interbody fusion with respect to a composite endpoint. The primary hypothesis for this study is that the probability of achieving 24-month composite clinical success (CCS) for subjects receiving the investigational device is not clinically inferior to the probability of achieving 24-month CCS for subjects receiving lumbar int