Spine DegenerationErYsNCT05170815
Clariance ErYs Registry
An observational study of Spine Degeneration and Spine Spondylosis Thoracic, run by Clariance at 1 site in France.
Trial summary
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Degeneration, Spine Spondylosis Thoracic, Spinal Deformity
- What is being tested?
- Spine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 760 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects with thoracolumbar disease, and who require spine surgery with Interbody Fusion Device and/or Posterior fixation System
Who may be able to join
- Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States).
- Indicated for treatment with one or more commercially available sponsor spine device included into the study.
- For France only, affiliated with or beneficiary of a social security scheme.
Who cannot join
- Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times).
- Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship).
- Contraindicated for spine surgery utilizing a commercially available sponsor spine device.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Santy Orthopedic Center
Lyon
Henri D'ASTORG, MD
About this study
Official title: Clariance Registry of ERISMA® and Idys® Devices
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF).
The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting.
The primary objective is to demonstrate that the use of the study devices is safe.
The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.
- Conditions
- Spine Degeneration, Spine Spondylosis Thoracic, Spinal Deformity, Spinal Tumor, Spinal Fracture
- Being tested
- Spine surgery
- Medical subject headings
- Spinal Cord Neoplasms, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine surgeryProcedure or surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
| Study group | Role | What they receive |
|---|---|---|
| ERISMA® LP/LP EVO | 120 subjects with ERISMA® LP/LP EVO implant Receives: Procedure: Spine surgery | |
| ERISMA® Deformity | 120 subjects with ERISMA® Deformity implant Receives: Procedure: Spine surgery | |
| ERISMA® MIS | 120 subjects with ERISMA® MIS implant Receives: Procedure: Spine surgery | |
| Idys® TLIF PEEK | 50 subjects with Idys® TLIF PEEK implant Receives: Procedure: Spine surgery | |
| Idys® TLIF TiVAC | 50 subjects with Idys® TLIF TiVAC implant Receives: Procedure: Spine surgery | |
| Idys® TLIF 3DTi | 50 subjects with Idys® TLIF 3DTi implant Receives: Procedure: Spine surgery | |
| Idys® ALIF PEEK | 50 subjects with Idys® ALIF PEEK implant Receives: Procedure: Spine surgery | |
| Idys® ALIF TiVAC | 50 subjects with Idys® ALIF TiVAC implant Receives: Procedure: Spine surgery | |
| Idys® ALIF 3DTi | 50 subjects with Idys® ALIF 3DTi implant Receives: Procedure: Spine surgery | |
| Idys® ALIF ZP 3DTi | 50 subjects with Idys® ALIF ZP 3DTi implant Receives: Procedure: Spine surgery | |
| Idys® LLIF 3DTi | 50 subjects with Idys® LLIF 3DTi implant Receives: Procedure: Spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision rate
Revision (each time a primary study implant is removed during an additional necessary surgery) rates, as a percentage of the total of cases per primary study device.
Measured: Year 2
Secondary outcomes (7)
Back & Leg Pain Visual Analog Score (VAS)
Self-report scale consisting in a 10-centimeter horizontal line with each end being an extreme label of the pain or discomfort experienced by the subject. The extreme labels are "no pain" (corresponding to the scale of 0) and "the worst pain imaginable" (corresponding to the scale of 100).
Measured: Pre-op; Week 9; Month 6; Year 1; Year 2
Oswestry Disability Index (ODI)
Self-report scale with 10 items each which 6 statements referring to the subject's life in different scenarios. The answers are scored on a 0 - 5 points scale that is then transformed to result in a score that ranges from 0% (indicating least disability) to 100% (indicating most disability).
Measured: Pre-op; Week 9; Month 6; Year 1; Year 2
Self-report multipurpose short-form (SF-12v2®)
The SF-12v2® measures eight components of general health: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological wellbeing).
Measured: Pre-op; Week 9; Month 6; Year 1; Year 2
Subject's Satisfaction
Five questions regarding the surgery outcomes, if the subject would recommend the surgery to family members and if the subject would still undergo the surgery. Each answer indicates a different level of satisfaction.
Measured: Week 9; Month 6; Year 1; Year 2
Radiological parameter: bony fusion
Evaluation of the interbody fusion from either X-rays or CT-scan images.
Measured: Week 9; Month 6; Year 1; Year 2
Adverse Events
Number of untoward medical occurrences, unintended diseases or injuries, or untoward clinical signs (including abnormal laboratory findings) in subjects , users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. May be serious or not.
Measured: Through study completion, an average of 2 years
Device Deficiencies
Number of inadequacies of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start17 Jan 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DegenerationStudies 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
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clariance
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170815
- Sponsor's protocol ID
- CSS-2021-01
- Acronym
- ErYs
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2021
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clariance Registry of ERISMA® and Idys® Devices
- ClinicalTrials.gov ID
- NCT05170815
- Acronym / sponsor ID
- ErYs / CSS-2021-01
- Conditions
- Spine Degeneration, Spine Spondylosis Thoracic, Spinal Deformity, Spinal Tumor, Spinal Fracture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- ClarianceIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Dec 2021 (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.
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF).
The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting.
The primary objective is to demonstrate that the use of the study devices is safe.
The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| ERISMA® LP/LP EVO | – | Procedure: Spine surgery120 subjects with ERISMA® LP/LP EVO implant |
| ERISMA® Deformity | – | Procedure: Spine surgery120 subjects with ERISMA® Deformity implant |
| ERISMA® MIS | – | Procedure: Spine surgery120 subjects with ERISMA® MIS implant |
| Idys® TLIF PEEK | – | Procedure: Spine surgery50 subjects with Idys® TLIF PEEK implant |
| Idys® TLIF TiVAC | – | Procedure: Spine surgery50 subjects with Idys® TLIF TiVAC implant |
| Idys® TLIF 3DTi | – | Procedure: Spine surgery50 subjects with Idys® TLIF 3DTi implant |
| Idys® ALIF PEEK | – | Procedure: Spine surgery50 subjects with Idys® ALIF PEEK implant |
| Idys® ALIF TiVAC | – | Procedure: Spine surgery50 subjects with Idys® ALIF TiVAC implant |
| Idys® ALIF 3DTi | – | Procedure: Spine surgery50 subjects with Idys® ALIF 3DTi implant |
| Idys® ALIF ZP 3DTi | – | Procedure: Spine surgery50 subjects with Idys® ALIF ZP 3DTi implant |
| Idys® LLIF 3DTi | – | Procedure: Spine surgery50 subjects with Idys® LLIF 3DTi implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with thoracolumbar disease, and who require spine surgery with Interbody Fusion Device and/or Posterior fixation System
Key inclusion criteria (3 listed)
- Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States).
- Indicated for treatment with one or more commercially available sponsor spine device included into the study.
- For France only, affiliated with or beneficiary of a social security scheme.
Key exclusion criteria (3 listed)
- Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times).
- Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship).
- Contraindicated for spine surgery utilizing a commercially available sponsor spine device.
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 surgeryImplantation of spine Interbody Fusion Devices and/or Posterior fixation System. | Procedure or surgery | ERISMA® Deformity, ERISMA® LP/LP EVO, ERISMA® MIS, Idys® ALIF 3DTi, Idys® ALIF PEEK, Idys® ALIF TiVAC, Idys® ALIF ZP 3DTi, Idys® LLIF 3DTi, Idys® TLIF 3DTi, Idys® TLIF PEEK, Idys® TLIF TiVAC |
Primary outcome
Revision rate
Time frame: Year 2
Revision (each time a primary study implant is removed during an additional necessary surgery) rates, as a percentage of the total of cases per primary study device.
7 secondary outcomes
Back & Leg Pain Visual Analog Score (VAS)
Time frame: Pre-op; Week 9; Month 6; Year 1; Year 2
Oswestry Disability Index (ODI)
Time frame: Pre-op; Week 9; Month 6; Year 1; Year 2
Self-report multipurpose short-form (SF-12v2®)
Time frame: Pre-op; Week 9; Month 6; Year 1; Year 2
Subject's Satisfaction
Time frame: Week 9; Month 6; Year 1; Year 2
Radiological parameter: bony fusion
Time frame: Week 9; Month 6; Year 1; Year 2
Adverse Events
Time frame: Through study completion, an average of 2 years
Device Deficiencies
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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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.
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 Spine Degeneration and Spine Spondylosis Thoracic, run by Clariance at 1 site in France.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Laboulfie (+33 7 81 20 03 13, f.laboulfie@clariance-spine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision rate (time frame: Year 2). 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 17 Mar 2026.