Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Clariance
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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.
