Degenerative Disc DiseaseNCT04584619
Idys™ TLIF 3DTi Post Market Clinical Follow-up
An observational study of Degenerative Disc Disease and Grade 1 Spondylolisthesis, run by Clariance at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Grade 1 Spondylolisthesis
- What is being tested?
- Spine fusion surgery with Clariance Idys TLIF 3DTi
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who need fusion of spinal lumbar segments
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Spine fusion surgery with Clariance Idys TLIF 3DTi
- Keywords
- Spine, Interbody fusion device
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine fusion surgery with Clariance Idys TLIF 3DTiDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the Fusion rate
Evolution of the radiological assessment of bony fusion at 3 different time point
Measured: 6 months, 12 months, 24 months postoperatively
Secondary outcomes (6)
Adverse events
To quantify and describe adverse events
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 6 weeks, 6 months, 12 months and 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clariance
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mukund Gundanna, Dr, Principal investigator, Brazos Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584619
- Sponsor's protocol ID
- 31PMCF-DrG
- Status last verified
- Nov 2021
- First submitted
- 30 Sep 2020
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clariance Idys™ TLIF 3DTi Device Prospective Post Market Clinical Follow-up
- ClinicalTrials.gov ID
- NCT04584619
- Acronym / sponsor ID
- 31PMCF-DrG
- Keywords
- Spine, Interbody fusion device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- ClarianceIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who need fusion of spinal lumbar segments
Key inclusion criteria (6 listed)
- English Speaking patients
- Patient with skeletal maturity
- Patient with
- Surgical treatment with Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine fusion surgery with Clariance Idys TLIF 3DTiPosterior 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). | Device | – |
Primary outcome
Evolution of the Fusion rate
Time frame: 6 months, 12 months, 24 months postoperatively
Evolution of the radiological assessment of bony fusion at 3 different time point
6 secondary outcomes
Adverse events
Time frame: Up to 24 months postoperatively
Evolution of the Patient Disability
Time frame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
Evolution of the Patient Pain
Time frame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
Radiologic Outcomes - Evolution of the lordosis angles (degree)
Time frame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
Radiologic Outcomes - Evolution of the Intervertebral Height (mm)
Time frame: Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively
Radiologic Outcomes - Stability of the Idys TLIF 3DTi Device
Time frame: 6 weeks, 6 months, 12 months and 24 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mukund Gundanna, Dr principal investigator
Brazos Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Grade 1 Spondylolisthesis, run by Clariance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the Fusion rate (time frame: 6 months, 12 months, 24 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.