Clariance ErYs Registry

Clariance

Status: Enrolling

Conditions: Spinal Tumor; Spinal Fracture; Spine Degeneration; Spinal Deformity; Spine Spondylosis Thoracic

Treatments: Procedure: Spine surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT05170815

CSS-2021-01

Details and patient eligibility

About

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.

Enrollment: 760 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

760 participants in 11 patient groups

ERISMA® LP/LP EVO

Description:

120 subjects with ERISMA® LP/LP EVO implant

Treatment:

Procedure: Spine surgery

ERISMA® Deformity

Description:

120 subjects with ERISMA® Deformity implant

Treatment:

Procedure: Spine surgery

ERISMA® MIS

Description:

120 subjects with ERISMA® MIS implant

Treatment:

Procedure: Spine surgery

Idys® TLIF PEEK

Description:

50 subjects with Idys® TLIF PEEK implant

Treatment:

Procedure: Spine surgery

Idys® TLIF TiVAC

Description:

50 subjects with Idys® TLIF TiVAC implant

Treatment:

Procedure: Spine surgery

Idys® TLIF 3DTi

Description:

50 subjects with Idys® TLIF 3DTi implant

Treatment:

Procedure: Spine surgery

Idys® ALIF PEEK

Description:

50 subjects with Idys® ALIF PEEK implant

Treatment:

Procedure: Spine surgery

Idys® ALIF TiVAC

Description:

50 subjects with Idys® ALIF TiVAC implant

Treatment:

Procedure: Spine surgery

Idys® ALIF 3DTi

Description:

50 subjects with Idys® ALIF 3DTi implant

Treatment:

Procedure: Spine surgery

Idys® ALIF ZP 3DTi

Description:

50 subjects with Idys® ALIF ZP 3DTi implant

Treatment:

Procedure: Spine surgery

Idys® LLIF 3DTi

Description:

50 subjects with Idys® LLIF 3DTi implant

Treatment:

Procedure: Spine surgery