NCT04584619

Idys™ TLIF 3DTi Post Market Clinical Follow-up

Clariance Idys™ TLIF 3DTi Device Prospective Post Market Clinical Follow-up

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Clariance · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Degenerative Disc Disease
• Grade 1 Spondylolisthesis

Interventions

Type	Name	Description
DEVICE	Spine fusion surgery with Clariance Idys TLIF 3DTi	Posterior fusion of the lumbar spine with Clariance Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2020-10-14
• Last updated: 2021-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study