Idys™ TLIF 3DTi Post Market Clinical Follow-up

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clariance Idys™ TLIF 3DTi Device Prospective Post Market Clinical Follow-up

Conditions
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Degenerative Disc Disease, Grade 1 Spondylolisthesis

Intervention / Treatment
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* Device: Spine fusion surgery with Clariance Idys TLIF 3DTi


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the Fusion rate | Evolution of the radiological assessment of bony fusion at 3 different time point | 6 months, 12 months, 24 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | To quantify and describe adverse events | 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) | 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) | 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 | 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. | Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively | 
| Radiologic Outcomes - Stability of the Idys TLIF 3DTi Device | Measurement ,on x-rays at different time points, of the anterior position of the Idys TLIF 3DTi device | 6 weeks, 6 months, 12 months and 24 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine, Interbody fusion device