Idys™ TLIF 3DTi Post Market Clinical Follow-up

Clariance25 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Disc Disease Grade 1 Spondylolisthesis

Interventions

Spine fusion surgery with Clariance Idys TLIF 3DTiDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Brazos Spine

College Station, Texas, United States

Outcomes

Primary Outcomes

Evolution of the Fusion rate

Evolution of the radiological assessment of bony fusion at 3 different time point

Time frame: 6 months, 12 months, 24 months postoperatively

Secondary Outcomes

Adverse events

To quantify and describe adverse events

Time frame: Up to 24 months postoperatively

Evolution of the Patient Disability

Assessment, at different time points, of the disability using Oswestry Disability Index score (range 0 to 100 with zero corresponding to no disability and 100 corresponding to the maximum disability possible)

Time frame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively

Evolution of the Patient Pain

Assessment, at different time points, of the pain using Visual Analogue Scale (range 0 to 10 with higher scores meaning a worse outcome)

Time frame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively

Radiologic Outcomes - Evolution of the lordosis angles (degree)

Measurements, on x-rays at different time points, of the lordosis angle at pathological / implanted level and of the global lordosis angle between L1/S1

Time frame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively

Radiologic Outcomes - Evolution of the Intervertebral Height (mm)

Measurements, on x-rays at different time points, of the anterior and the posterior inter-vertebral height.

Time frame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively

Data from ClinicalTrials.gov

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