Degenerative Disc Disease, Grade 1 Spondylolisthesis
Conditions
Keywords
Spine, Interbody fusion device
Brief 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.
Detailed 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 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.
Interventions
DEVICESpine 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).
Sponsors
Clariance
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the Fusion rate | 6 months, 12 months, 24 months postoperatively | Evolution of the radiological assessment of bony fusion at 3 different time point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the Patient Disability | Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively | 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) |
| Evolution of the Patient Pain | Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively | Assessment, at different time points, of the pain using Visual Analogue Scale (range 0 to 10 with higher scores meaning a worse outcome) |
| Adverse events | Up to 24 months postoperatively | To quantify and describe adverse events |
| Radiologic Outcomes - Evolution of the Intervertebral Height (mm) | Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively | Measurements, on x-rays at different time points, of the anterior and the posterior inter-vertebral height. |
| Radiologic Outcomes - Stability of the Idys TLIF 3DTi Device | 6 weeks, 6 months, 12 months and 24 months postoperatively | Measurement ,on x-rays at different time points, of the anterior position of the Idys TLIF 3DTi device |
| Radiologic Outcomes - Evolution of the lordosis angles (degree) | Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively | 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 |
Countries
United States
Outcome results
None listed