Vertebral Compression Fracture
Conditions
Brief summary
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.
Interventions
DEVICEV-STRUT
Minimally invasive implantation of V-STRUT
Sponsors
Hyprevention
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difficulties of the procedure [feasibility of the procedure] | 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. |
| Type of anaesthesia [feasibility of the procedure] | per-operative | Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other. |
| Cement quantity injected [feasibility of the procedure] | per-operative | Record cement quantity injected in the vertebral body, in cc (cubic centimeter). |
| Operating time [feasibility of the procedure] | per-operative | Measuring the duration of the surgical procedures. |
| Hospitalisation stay [feasibility of the procedure] | per-operative and immediate post-op | Measuring the duration of the hospitalisation stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haematomas and infections rates [safety of the device] | per-operative, immediate post-op, at 2 months, 6 months and 12 months. | Measuring haematomas and infections rates. |
| Pain [performance of the device] | 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). |
| Wound healing [safety of the device] | per-operative, immediate post-op, at 2 months, 6 months and 12 months. | Assessment of wound-healing by practitioners. |
| Frequencies of ADEs and SADEs [safety of the device] | 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). |
| Rates of cement leakage [safety of the device] | Per-operative, immediate post-op, at 2 months, 6 months and 12 months. | Measuring the rates of cement leakages. |
| Rates of fractures [safety of the device] | Per-operative, immediate post-op, at 2 months, 6 months and 12 months. | Measuring the rates of subsequent, adjacent and pedicle fractures. |
| Functional score [safety of the device] | 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. |
Countries
France
Outcome results
None listed