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NCT Number: NCT05170815

Clariance ErYs Registry

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.

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Key information

Conditions

Spine Degeneration Back Injuries Central Nervous System Diseases Central Nervous System Neoplasms Fractures, Bone Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Spinal Cord Diseases Spinal Cord Neoplasms Spinal Deformity Spinal Fracture Spinal Fractures Spinal Injuries Spinal Tumor Spine Spondylosis Thoracic Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Santy Orthopedic Center

Lyon, France

Location status: Recruiting

Location contact

Henri D'ASTORG, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spine surgery

Procedure

Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Back & Leg Pain Visual Analog Score (VAS)

    Time frame: 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).

  2. Oswestry Disability Index (ODI)

    Time frame: 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).

  3. Self-report multipurpose short-form (SF-12v2®)

    Time frame: 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).

  4. Subject's Satisfaction

    Time frame: 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.

  5. Radiological parameter: bony fusion

    Time frame: Week 9; Month 6; Year 1; Year 2

    Evaluation of the interbody fusion from either X-rays or CT-scan images.

  6. Adverse Events

    Time frame: 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.

  7. Device Deficiencies

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Florian Laboulfie

CONTACT

[email protected]

+33 7 81 20 03 13

Sponsors and collaborators

Lead sponsor

Clariance

Industry

Registry information

Official study title

Clariance Registry of ERISMA® and Idys® Devices

Acronym: ErYs

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Dec 28, 2021
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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