Clinical trial NCT04584619: Idys™ TLIF 3DTi Post Market Clinical Follow-up
Official title: Clariance Idys™ TLIF 3DTi Device Prospective Post Market Clinical Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Disc Disease
Grade 1 Spondylolisthesis
Keywords: Spine
Interbody fusion device
Lead sponsor: Clariance
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who need fusion of spinal lumbar segments

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of the Fusion rate
timeFrame: 6 months, 12 months, 24 months postoperatively
Secondary outcomes:
measure: Adverse events
timeFrame: Up to 24 months postoperatively
measure: Evolution of the Patient Disability
timeFrame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
measure: Evolution of the Patient Pain
timeFrame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
measure: Radiologic Outcomes - Evolution of the lordosis angles (degree)
timeFrame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
measure: Radiologic Outcomes - Evolution of the Intervertebral Height (mm)
timeFrame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
measure: Radiologic Outcomes - Stability of the Idys TLIF 3DTi Device
timeFrame: 6 weeks, 6 months, 12 months and 24 months postoperatively
Other outcomes:
Locations:
city: College Station
country: United States
facility: Brazos Spine
state: Texas
Study officials:
affiliation: Brazos Spine
name: Mukund Gundanna, Dr
role: PRINCIPAL_INVESTIGATOR
References: