Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease (TLIF)

August 16, 2023 updated by: SpineVision

Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study

The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down).

Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF (prospective subjects) can be enrolled in the study.

Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS), Oswestry Disability Index (ODI) score, and adverse events.

Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.

Study Type

Observational

Enrollment (Estimated)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bruges, France
        • Recruiting
        • Clinique du Dos Terrefort
        • Contact:
        • Principal Investigator:
          • Ibrahim Obeid, Doctor
        • Sub-Investigator:
          • Louis Boissière, Doctor
      • Lyon, France
        • Recruiting
        • Clinique Saint Charles
        • Contact:
        • Principal Investigator:
          • Emmanuel Favreul, Doctor
      • Marseille, France
        • Recruiting
        • Hôpital privé Clairval
        • Contact:
        • Principal Investigator:
          • Noel Graziani, Professor
      • Nancy, France
        • Recruiting
        • CHRU Nancy
        • Contact:
        • Principal Investigator:
          • Nacer Mansouri, Doctor
      • Nancy, France
        • Recruiting
        • Polyclinique Majorelle
        • Contact:
        • Principal Investigator:
          • Aurélie Toquart, Doctor
  • Switzerland
      • Geneva, Switzerland
        • Not yet recruiting
        • Clinicque Générale Beaulieu
        • Contact:
        • Principal Investigator:
          • Frédéric Schils, Doctor
        • Sub-Investigator:
          • Renato Gondar, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients eligible for treatment or already treated with the Hexanium TLIF system device will be offered to participate in the study; this applies to primary care clinic.

Description

Inclusion Criteria:

  • Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)
  • Patient of 18 years old or more
  • Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation

Exclusion Criteria: contra-indication

  • Infection, local to the operative site
  • Signed of local inflammation
  • Fever or leukocytosis
  • Morbid obesity
  • Pregnancy
  • Paediatric cases, or patient still having general skeletal growth
  • Spondylolisthesis unable to be reduced to Grade I
  • Suspected or documented allergy or intolerance to metal
  • Any case where the implant components selected for use would be too large or too small to achieve a successful result
  • Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
  • Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
  • Prior fusion at the level to be treated
  • Any case not needing a bone graft or fusion
  • Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
  • Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count
  • Mental illness
  • Any patient unwilling to cooperate with post-operative instructions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious adverse device and/or procedure related events
Time Frame: Month 24
Rate of the serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.
Month 24
Change of the Oswestry Disability Index (ODI)
Time Frame: Month 12
ODI mean score at Month 12 will be compared to the ODI mean score at baseline.
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion success
Time Frame: Month 2, month 6, month 12 and month 24
Fusion rate will be analyzed and compared to the state of the art.
Month 2, month 6, month 12 and month 24
Incidence of revision surgery at implant site
Time Frame: Month 2, month 6, month 12 and month 24
Rate of revision surgery at implant site will be analyzed and compared to the state of the art.
Month 2, month 6, month 12 and month 24
Change of the Oswestry Disability Index (ODI)
Time Frame: Month 2, month 6, and month 24
Mean ODI score evolution score will be analyzed.
Month 2, month 6, and month 24
Change of the back and leg Visual Analogue Score (VAS)
Time Frame: Month 2, month 6, month 12 and month 24
Back and leg VAS assessment will be analyzed.
Month 2, month 6, month 12 and month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SpineVision

Collaborators

EVAMED

Investigators

  • Principal Investigator: Noel Graziani, Professor, Hôpital privé Clairval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2021

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SV005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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