Clariance Registry of ERISMA® and Idys® Devices

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Santy Orthopedic Center
RECRUITING
Lyon
Contact Information
Primary
Florian Laboulfie
f.laboulfie@clariance-spine.com
+33 7 81 20 03 13
Time Frame
Start Date: 2022-01-17
Estimated Completion Date: 2025-12
Participants
Target number of participants: 760
Treatments
ERISMA® LP/LP EVO
120 subjects with ERISMA® LP/LP EVO implant
ERISMA® Deformity
120 subjects with ERISMA® Deformity implant
ERISMA® MIS
120 subjects with ERISMA® MIS implant
Idys® TLIF PEEK
50 subjects with Idys® TLIF PEEK implant
Idys® TLIF TiVAC
50 subjects with Idys® TLIF TiVAC implant
Idys® TLIF 3DTi
50 subjects with Idys® TLIF 3DTi implant
Idys® ALIF PEEK
50 subjects with Idys® ALIF PEEK implant
Idys® ALIF TiVAC
50 subjects with Idys® ALIF TiVAC implant
Idys® ALIF 3DTi
50 subjects with Idys® ALIF 3DTi implant
Idys® ALIF ZP 3DTi
50 subjects with Idys® ALIF ZP 3DTi implant
Idys® LLIF 3DTi
50 subjects with Idys® LLIF 3DTi implant
Related Therapeutic Areas
Sponsors
Leads: Clariance

This content was sourced from clinicaltrials.gov