The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System

August 1, 2022 updated by: Hyprevention

National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment

The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Bordeaux, France
        • Polyclinique Bordeaux Nord Aquitaine
      • Paris, France, 75020
        • APHP - Hôpital Tenon
      • Villejuif, France
        • Institut Gustave Roussy

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Adult male and female patients
  • Treatment of vertebral compression fracture (type A.1, some A.2 and rarely A.3 Magerl classification)
  • Due to osteoporosis or tumorous lesions,
  • Located in the thoracic and/or lumbar spine from T9 to L5.
  • One unique vertebral fracture to be treated with the device
  • Pain > 4
  • ASA > 5
  • For osteoporotic patient, fail in conservative treatment (8 days of antalgic medication Level III) and recent fracture (less than 6 weeks).

Exclusion Criteria:

  • Unstable fractures or neoplasms with posterior involvement
  • Nonmobile fractures
  • Damages of the pedicles or posterior wall
  • Less than one third of the original vertebral body height remaining
  • Spinal canal stenosis (>20%)
  • Neurologic signs or symptoms related to the compression fracture or impeding pathological fracture
  • Patient clearly improving on conservative treatment
  • Pregnancy, breastfeeding
  • Any contra-indication / allergy to implant material or cement
  • Any previous surgical treatment (material or cement) in the targeted vertebra
  • Systemic infection or infection located in the spine
  • Any medical condition including but not limited to anaemia, coagulation disorders, fibromyalgia, algoneurodystrophy, Paget's disease, uncontrolled diabetes that would preclude the patient from having surgery or would impede the benefit of surgery
  • Patient under the age of majority

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: V-STRUT
V-STRUT implantation
Device: V-STRUT
Minimally invasive implantation of V-STRUT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulties of the procedure [feasibility of the procedure]
Time Frame: per-operative
Record difficulties experienced by surgeons during the procedure: each individual step of the procedure will be recorded and quoted by practitioners as very easy, easy, difficult or very difficult.
per-operative
Type of anaesthesia [feasibility of the procedure]
Time Frame: per-operative
Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other.
per-operative
Cement quantity injected [feasibility of the procedure]
Time Frame: per-operative
Record cement quantity injected in the vertebral body, in cc (cubic centimeter).
per-operative
Operating time [feasibility of the procedure]
Time Frame: per-operative
Measuring the duration of the surgical procedures.
per-operative
Hospitalisation stay [feasibility of the procedure]
Time Frame: per-operative and immediate post-op
Measuring the duration of the hospitalisation stay.
per-operative and immediate post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain [performance of the device]
Time Frame: pre- operative, immediate post-op, at 2 months, 6 months and 12 months.
Self-evaluation of pain using Visual Analogue Scale (VAS) going from 0 (no pain) to 10 (maximum).
pre- operative, immediate post-op, at 2 months, 6 months and 12 months.
Frequencies of ADEs and SADEs [safety of the device]
Time Frame: per- operative, immediate post-op, at 2 months, 6 months and 12 months.
Measuring the frequencies of Adverse Device-related Events (ADEs) and Severe Adverse Device-related Events (SADEs).
per- operative, immediate post-op, at 2 months, 6 months and 12 months.
Rates of cement leakage [safety of the device]
Time Frame: Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Measuring the rates of cement leakages.
Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Rates of fractures [safety of the device]
Time Frame: Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Measuring the rates of subsequent, adjacent and pedicle fractures.
Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Functional score [safety of the device]
Time Frame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Measuring patient's disability using the 100 points ODI (Oswestry Disability Index) functional score.
per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Haematomas and infections rates [safety of the device]
Time Frame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Measuring haematomas and infections rates.
per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Wound healing [safety of the device]
Time Frame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Assessment of wound-healing by practitioners.
per-operative, immediate post-op, at 2 months, 6 months and 12 months.

Collaborators and Investigators

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

Sponsor

Hyprevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2019

Primary Completion (ACTUAL)

August 1, 2022

Study Completion (ACTUAL)

August 1, 2022

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (ACTUAL)

July 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPINE0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data analysis of the investigation will carry out a final report that will be sent to the CPP and ANSM.

According to the law N°2002-303 dated March 4, 2002, the patients involved in the study will be informed on demand on the global data analysis.

Regarding publication, if the data analysis provides important and interesting information on the device and its associated procedure for the treatment of vertebral compression fracture which aims to complete the state of the art, it may be decided to publish the corresponding data. In this case, the IPD that will be shared will consists of all IPD that underlie results in this publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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