The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System
- Conditions
- Vertebral Compression Fracture
- Interventions
- Device: V-STRUT
- Registration Number
- NCT03580434
- Lead Sponsor
- Hyprevention
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description V-STRUT V-STRUT V-STRUT implantation
- Primary Outcome Measures
Name Time Method 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.
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.
Type of anaesthesia [feasibility of the procedure] per-operative Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other.
- Secondary Outcome Measures
Name Time Method 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.
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).
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.
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.
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).
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.
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.
Trial Locations
- Locations (3)
APHP - Hôpital Tenon
🇫🇷Paris, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Institut Gustave Roussy
🇫🇷Villejuif, France