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Recruiting NCT05170815

Clariance ErYs Registry

— Observational Spine Degeneration Spine Spondylosis Thoracic Spinal Deformity Spinal Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spine surgery.
Who it may be relevant to
Registry conditions: Spine Degeneration, Spine Spondylosis Thoracic, Spinal Deformity, Spinal Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clariance Registry of ERISMA® and Idys® Devices

Overview

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.

Interventions

  • Procedure Spine surgery
    Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.

Primary outcome measures

  • Revision rate [Time frame: Year 2]
Secondary outcome measures (7)
  • Back & Leg Pain Visual Analog Score (VAS) [Time frame: Pre-op; Week 9; Month 6; Year 1; Year 2]
  • Oswestry Disability Index (ODI) [Time frame: Pre-op; Week 9; Month 6; Year 1; Year 2]
  • Self-report multipurpose short-form (SF-12v2®) [Time frame: Pre-op; Week 9; Month 6; Year 1; Year 2]
  • Subject's Satisfaction [Time frame: Week 9; Month 6; Year 1; Year 2]
  • Radiological parameter: bony fusion [Time frame: Week 9; Month 6; Year 1; Year 2]
  • Adverse Events [Time frame: Through study completion, an average of 2 years]
  • Device Deficiencies [Time frame: Through study completion, an average of 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Santy Orthopedic Center — Lyon

Identifiers

NCT: NCT05170815 · CSS-2021-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗