Idys™ TLIF 3DTi Post Market Clinical Follow-up
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Degenerative Disc Disease
- Grade 1 Spondylolisthesis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 p...
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.
Tracking Information
- NCT #
- NCT04584619
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Mukund Gundanna, Dr Brazos Spine
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