Idys™ TLIF 3DTi Post Market Clinical Follow-up

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Disc Disease; Grade 1 Spondylolisthesis
• Intervention / Treatment: Device: Spine fusion surgery with Clariance Idys TLIF 3DTi

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.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77845
      • Brazos Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who need fusion of spinal lumbar segments

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clariance
• Investigators: Principal Investigator: Mukund Gundanna, Dr, Brazos Spine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Spine; Interbody fusion device
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: 31PMCF-DrG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No