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Idys™ TLIF 3DTi Post Market Clinical Follow-up

NCT04584619 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2021-11-29

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease
  • Grade 1 Spondylolisthesis

Interventions

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).

Sponsors & Collaborators

  • Clariance

    lead INDUSTRY

Principal Investigators

  • Mukund Gundanna, Dr · Brazos Spine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-09-30
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584619 on ClinicalTrials.gov