UnknownNot Applicable

Idys™ TLIF 3DTi Post Market Clinical Follow-up

United States25 participantsStarted 2020-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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

What they're measuring

Evolution of the Fusion rate

Timeframe: 6 months, 12 months, 24 months postoperatively

Trial details

NCT IDNCT04584619

SponsorClariance

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Degenerative Disc Disease trials