NCT05170815

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
760

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jan 2022Dec 2028

First Submitted

Initial submission to the registry

November 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6.9 years

First QC Date

November 25, 2021

Last Update Submit

March 16, 2026

Conditions

Spine DegenerationSpine Spondylosis ThoracicSpinal DeformitySpinal TumorSpinal Fracture

Outcome Measures

Primary Outcomes (1)

  • Revision rate

    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.

    Year 2

Secondary Outcomes (7)

  • Back & Leg Pain Visual Analog Score (VAS)

    Pre-op; Week 9; Month 6; Year 1; Year 2

  • Oswestry Disability Index (ODI)

    Pre-op; Week 9; Month 6; Year 1; Year 2

  • Self-report multipurpose short-form (SF-12v2®)

    Pre-op; Week 9; Month 6; Year 1; Year 2

  • Subject's Satisfaction

    Week 9; Month 6; Year 1; Year 2

  • Radiological parameter: bony fusion

    Week 9; Month 6; Year 1; Year 2

  • +2 more secondary outcomes

Study Arms (11)

ERISMA® LP/LP EVO

120 subjects with ERISMA® LP/LP EVO implant

Procedure: Spine surgery

ERISMA® Deformity

120 subjects with ERISMA® Deformity implant

Procedure: Spine surgery

ERISMA® MIS

120 subjects with ERISMA® MIS implant

Procedure: Spine surgery

Idys® TLIF PEEK

50 subjects with Idys® TLIF PEEK implant

Procedure: Spine surgery

Idys® TLIF TiVAC

50 subjects with Idys® TLIF TiVAC implant

Procedure: Spine surgery

Idys® TLIF 3DTi

50 subjects with Idys® TLIF 3DTi implant

Procedure: Spine surgery

Idys® ALIF PEEK

50 subjects with Idys® ALIF PEEK implant

Procedure: Spine surgery

Idys® ALIF TiVAC

50 subjects with Idys® ALIF TiVAC implant

Procedure: Spine surgery

Idys® ALIF 3DTi

50 subjects with Idys® ALIF 3DTi implant

Procedure: Spine surgery

Idys® ALIF ZP 3DTi

50 subjects with Idys® ALIF ZP 3DTi implant

Procedure: Spine surgery

Idys® LLIF 3DTi

50 subjects with Idys® LLIF 3DTi implant

Procedure: Spine surgery

Interventions

Spine surgeryPROCEDURE

Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.

ERISMA® DeformityERISMA® LP/LP EVOERISMA® MISIdys® ALIF 3DTiIdys® ALIF PEEKIdys® ALIF TiVACIdys® ALIF ZP 3DTiIdys® LLIF 3DTiIdys® TLIF 3DTiIdys® TLIF PEEKIdys® TLIF TiVAC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with thoracolumbar disease, and who require spine surgery with Interbody Fusion Device and/or Posterior fixation System

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santy Orthopedic Center

Lyon, France

RECRUITING

MeSH Terms

Conditions

Spinal Cord NeoplasmsSpinal Fractures

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Florian Laboulfie

CONTACT

+33 7 81 20 03 13f.laboulfie@clariance-spine.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 28, 2021

Study Start

January 17, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations

FR(1)