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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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