Clariance ErYs Registry

Recruiting

• Conditions: Spine Degeneration; Spine Spondylosis Thoracic; Spinal Deformity; Spinal Tumor; Spinal Fracture
• Interventions: Procedure: Spine surgery

• Registration Number: NCT05170815
• Lead Sponsor: Clariance

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-28
• Study Start: 2022-01-17
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 760

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Idys® TLIF 3DTi	Spine surgery	50 subjects with Idys® TLIF 3DTi implant
ERISMA® LP/LP EVO	Spine surgery	120 subjects with ERISMA® LP/LP EVO implant
ERISMA® Deformity	Spine surgery	120 subjects with ERISMA® Deformity implant
ERISMA® MIS	Spine surgery	120 subjects with ERISMA® MIS implant
Idys® LLIF 3DTi	Spine surgery	50 subjects with Idys® LLIF 3DTi implant
Idys® ALIF PEEK	Spine surgery	50 subjects with Idys® ALIF PEEK implant
Idys® ALIF TiVAC	Spine surgery	50 subjects with Idys® ALIF TiVAC implant
Idys® TLIF PEEK	Spine surgery	50 subjects with Idys® TLIF PEEK implant
Idys® ALIF ZP 3DTi	Spine surgery	50 subjects with Idys® ALIF ZP 3DTi implant
Idys® ALIF 3DTi	Spine surgery	50 subjects with Idys® ALIF 3DTi implant
Idys® TLIF TiVAC	Spine surgery	50 subjects with Idys® TLIF TiVAC implant

Primary Outcome Measures

Name	Time	Method
Revision rate	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.

Secondary Outcome Measures

Name	Time	Method
Back & Leg Pain Visual Analog Score (VAS)	Pre-op; Week 9; Month 6; Year 1; Year 2	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).
Subject's Satisfaction	Week 9; Month 6; Year 1; Year 2	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.
Radiological parameter: bony fusion	Week 9; Month 6; Year 1; Year 2	Evaluation of the interbody fusion from either X-rays or CT-scan images.
Adverse Events	Through study completion, an average of 2 years	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.
Device Deficiencies	Through study completion, an average of 2 years	Number of inadequacies of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.
Self-report multipurpose short-form (SF-12v2®)	Pre-op; Week 9; Month 6; Year 1; Year 2	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).
Oswestry Disability Index (ODI)	Pre-op; Week 9; Month 6; Year 1; Year 2	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).

Trial Locations

Locations (1)

Santy Orthopedic Center; 🇫🇷 Lyon, France