Clariance ErYs Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClariance
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Subjects with thoracolumbar disease, and who require spine surgery with Interbody Fusion Device and/or Posterior fixation System
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Spine surgery
Procedure/SurgeryImplantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Treatment groups
760 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Group A: ERISMA® LP/LP EVO1 intervention
Group B: ERISMA® Deformity1 intervention
Group C: ERISMA® MIS1 intervention
Group D: Idys® TLIF PEEK1 intervention
Group E: Idys® TLIF TiVAC1 intervention
Group F: Idys® TLIF 3DTi1 intervention
Group G: Idys® ALIF PEEK1 intervention
Group H: Idys® ALIF TiVAC1 intervention
Group I: Idys® ALIF 3DTi1 intervention
Group J: Idys® ALIF ZP 3DTi1 intervention
Group K: Idys® LLIF 3DTi1 intervention
Trial outcomes
Primary outcomes
1
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 2Secondary outcomes
1
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 22
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 23
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 24
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 Source ClinicalTrials.gov