Clinical Trial Finder

Idys™ TLIF 3DTi Post Market Clinical Follow-up

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04584619
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Clariance
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Mukund Gundanna, Dr
Principal Investigator Affiliation Brazos Spine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Degenerative Disc Disease, Grade 1 Spondylolisthesis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brazos Spine, College Station, Texas

Status

Recruiting

Address

Brazos Spine

College Station, Texas, 77845

Site Contact

Hannah Hagler

[email protected]

979-693-1815

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