Idys™ TLIF 3DTi Post Market Clinical Follow-up

Status Active, not recruiting

Clinical Trial Summary

The aim of this observational post-marketing study is to provide additional information on the safety and effectiveness of Idys™ TLIF 3DTi at up to 24 months post transforaminal lumbar fusion in usual surgical practice.

Clinical Trial Description

The primary endpoint is to evaluate the effectiveness of the Idys™ TLIF (Transforaminal Lumbar Interbody Fusion) 3DTi (Porous Titanium additive manufacturing) by measuring the evolution of the rate of fusion during the postoperative period. The secondary endpoints are to analyze the safety and the patient's benefit of the Idys™ TLIF 3DTi by evaluating several point of view: - The adverse events related to the surgery; - The functional improvement between preoperative state and the different follow-up time points using the Oswestry Disability Index (ODI); - The improvement of back pain between preoperative state and the different follow-up time points using the Visual Analog Scale (VAS) (legs and back); - The evolution of several radiologic lumbar parameters to assess the correction and its stability. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04584619
Study type	Observational
Source	Clariance
Contact
Status	Active, not recruiting
Phase
Start date	October 1, 2020
Completion date	December 31, 2023

View Details

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