Clariance ErYs Registry (ErYs)

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.

Study Overview

• Status: Recruiting
• Conditions: Spine Degeneration; Spinal Tumor; Spinal Deformity; Spinal Fracture; Spine Spondylosis Thoracic
• Intervention / Treatment: Procedure: Spine surgery

• Study Type: Observational
• Enrollment (Anticipated): 760

Contacts and Locations

• Study Contact: Name: Florian Laboulfie; Phone Number: +33 7 81 20 03 13; Email: f.laboulfie@clariance-spine.com

Study Locations

• France
  • Lyon, France
    • Recruiting
    • Santy orthopedic center
    • Contact: Henri D'ASTORG, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with thoracolumbar disease, and who require spine surgery with Interbody Fusion Device and/or Posterior fixation System

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

11

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ERISMA® LP/LP EVO; 120 subjects with ERISMA® LP/LP EVO implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
ERISMA® Deformity; 120 subjects with ERISMA® Deformity implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
ERISMA® MIS; 120 subjects with ERISMA® MIS implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® TLIF PEEK; 50 subjects with Idys® TLIF PEEK implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® TLIF TiVAC; 50 subjects with Idys® TLIF TiVAC implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® TLIF 3DTi; 50 subjects with Idys® TLIF 3DTi implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® ALIF PEEK; 50 subjects with Idys® ALIF PEEK implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® ALIF TiVAC; 50 subjects with Idys® ALIF TiVAC implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® ALIF 3DTi; 50 subjects with Idys® ALIF 3DTi implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® ALIF ZP 3DTi; 50 subjects with Idys® ALIF ZP 3DTi implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® LLIF 3DTi; 50 subjects with Idys® LLIF 3DTi implant	Procedure: Spine surgery; Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Year 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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.	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.	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.	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Clariance

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2022
• Primary Completion (ANTICIPATED): December 1, 2025
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (ACTUAL): December 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Spinal Injuries; Back Injuries; Bone Neoplasms; Spinal Fractures; Spondylosis; Spinal Cord Neoplasms; Spinal Neoplasms
• Other Study ID Numbers: CSS-2021-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes