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Completed

NCT Number: NCT03580434

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

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.

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Key information

Conditions

Vertebral Compression Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V-STRUT

Device

Minimally invasive implantation of V-STRUT

Primary outcomes

  1. 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.

  2. 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.

  3. Cement quantity injected [feasibility of the procedure]

    Time frame: per-operative

    Record cement quantity injected in the vertebral body, in cc (cubic centimeter).

  4. Operating time [feasibility of the procedure]

    Time frame: per-operative

    Measuring the duration of the surgical procedures.

  5. Hospitalisation stay [feasibility of the procedure]

    Time frame: per-operative and immediate post-op

    Measuring the duration of the hospitalisation stay.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Hyprevention

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2018
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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