Idys™ TLIF 3DTi Post Market Clinical Follow-up
Clariance Idys™ TLIF 3DTi Device Prospective Post Market Clinical Follow-up
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedNovember 29, 2021
November 1, 2021
3 years
September 30, 2020
November 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Adverse events
Up to 24 months postoperatively
Evolution of the Patient Disability
Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
Evolution of the Patient Pain
Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
Radiologic Outcomes - Evolution of the lordosis angles (degree)
Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
Radiologic Outcomes - Evolution of the Intervertebral Height (mm)
Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
- +1 more secondary outcomes
Interventions
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).
Eligibility Criteria
Patient who need fusion of spinal lumbar segments
You may qualify 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 qualify 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.
- Any patient being vulnerable
- Non-English speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clariancelead
Study Sites (1)
Brazos Spine
College Station, Texas, 77845, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mukund Gundanna, Dr
Brazos Spine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 14, 2020
Study Start
October 1, 2020
Primary Completion
September 30, 2023
Study Completion
December 31, 2023
Last Updated
November 29, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share