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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vertebral Compression Fracture

Intervention / Treatment
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* Device: V-STRUT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V-STRUT<br>V-STRUT implantation | Device: V-STRUT<br>* Minimally invasive implantation of V-STRUT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulties of the procedure [feasibility of the procedure] | 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] | Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other. | per-operative | 
| Cement quantity injected [feasibility of the procedure] | Record cement quantity injected in the vertebral body, in cc (cubic centimeter). | per-operative | 
| Operating time [feasibility of the procedure] | Measuring the duration of the surgical procedures. | per-operative | 
| Hospitalisation stay [feasibility of the procedure] | 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] | 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] | 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] | 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] | 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] | 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] | Measuring haematomas and infections rates. | per-operative, immediate post-op, at 2 months, 6 months and 12 months. | 
| Wound healing [safety of the device] | Assessment of wound-healing by practitioners. | per-operative, immediate post-op, at 2 months, 6 months and 12 months. |