Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
760 participants
OBSERVATIONAL
2022-01-17
2025-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ERISMA® LP/LP EVO
120 subjects with ERISMA® LP/LP EVO implant
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
ERISMA® Deformity
120 subjects with ERISMA® Deformity implant
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
ERISMA® MIS
120 subjects with ERISMA® MIS implant
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® TLIF PEEK
50 subjects with Idys® TLIF PEEK implant
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® TLIF TiVAC
50 subjects with Idys® TLIF TiVAC implant
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® TLIF 3DTi
50 subjects with Idys® TLIF 3DTi implant
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® ALIF PEEK
50 subjects with Idys® ALIF PEEK implant
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® ALIF TiVAC
50 subjects with Idys® ALIF TiVAC implant
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® ALIF 3DTi
50 subjects with Idys® ALIF 3DTi implant
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
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Idys® LLIF 3DTi
50 subjects with Idys® LLIF 3DTi implant
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Interventions
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Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Clariance
INDUSTRY
Responsible Party
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Locations
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Santy Orthopedic Center
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Henri D'ASTORG, MD
Role: primary
Other Identifiers
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CSS-2021-01
Identifier Type: -
Identifier Source: org_study_id
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