An observational study in Spine Degeneration, Spine Spondylosis Thoracic and Spinal Deformity, sponsored by Clariance. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Clariance · Observational
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.
88 studies on the registry are indexed under Spinal Cord Neoplasms; 26 are open to participants now.
This study's planned enrollment of 760 is above the median of 150 across 31 observational studies indexed under Spinal Cord Neoplasms.
Browse Spinal Cord Neoplasms studies →Clariance is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with thoracolumbar disease, and who require spine surgery with Interbody Fusion Device and/or Posterior fixation System
Exclusion Criteria:
120 subjects with ERISMA® LP/LP EVO implant
Procedure: Spine surgery
120 subjects with ERISMA® Deformity implant
Procedure: Spine surgery
120 subjects with ERISMA® MIS implant
Procedure: Spine surgery
50 subjects with Idys® TLIF PEEK implant
Procedure: Spine surgery
50 subjects with Idys® TLIF TiVAC implant
Procedure: Spine surgery
50 subjects with Idys® TLIF 3DTi implant
Procedure: Spine surgery
50 subjects with Idys® ALIF PEEK implant
Procedure: Spine surgery
50 subjects with Idys® ALIF TiVAC implant
Procedure: Spine surgery
50 subjects with Idys® ALIF 3DTi implant
Procedure: Spine surgery
50 subjects with Idys® ALIF ZP 3DTi implant
Procedure: Spine surgery
50 subjects with Idys® LLIF 3DTi implant
Procedure: Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
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.
Time frame: Year 2
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 2 years
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