Idys™ TLIF 3DTi Post Market Clinical Follow-up

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04584619
• Other study ID #: 31PMCF-DrG
• Status: Active, not recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Clariance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Grade 1 Spondylolisthesis
• Intervertebral Disc Degeneration
• Spondylolisthesis

Intervention

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).

Locations

Country	Name	City	State
United States	Brazos Spine	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Clariance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	To quantify and describe adverse events	Up to 24 months postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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