Idys™ TLIF 3DTi Post Market Clinical Follow-up

Status unconfirmed

Conditions studied: Degenerative Disc Disease, Grade 1 Spondylolisthesis

In brief

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.

Key facts

Study ID

NCT04584619

Run by

Clariance

People needed

25

Starts

2020-10-01

Expected to finish

2023-12-31

Last updated by the study team

2021-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English Speaking patients
• Patient with skeletal maturity
• Patient with
• degenerative disc disease at one or two levels from L2 to S1 and/or
• grade 1 spondylolisthesis
• Surgical treatment with Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).

You may not qualify if…

• Off-label indications.
• Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
• Any patient having a prior fusion at the level to be treated.
• Any patient being vulnerable
• Non-English speakers

Where it is running

• Brazos Spine — College Station, Texas, United States

Full record on ClinicalTrials.gov

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