Clinical trial NCT03580434: The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System
Official title: National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertebral Compression Fracture
Lead sponsor: Hyprevention
Sponsor class: INDUSTRY
First posted: 2018-07-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difficulties of the procedure [feasibility of the procedure]
timeFrame: per-operative
measure: Type of anaesthesia [feasibility of the procedure]
timeFrame: per-operative
measure: Cement quantity injected [feasibility of the procedure]
timeFrame: per-operative
measure: Operating time [feasibility of the procedure]
timeFrame: per-operative
measure: Hospitalisation stay [feasibility of the procedure]
timeFrame: per-operative and immediate post-op
Secondary outcomes:
measure: Pain [performance of the device]
timeFrame: pre- operative, immediate post-op, at 2 months, 6 months and 12 months.
measure: Frequencies of ADEs and SADEs [safety of the device]
timeFrame: per- operative, immediate post-op, at 2 months, 6 months and 12 months.
measure: Rates of cement leakage [safety of the device]
timeFrame: Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
measure: Rates of fractures [safety of the device]
timeFrame: Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
measure: Functional score [safety of the device]
timeFrame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
measure: Haematomas and infections rates [safety of the device]
timeFrame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
measure: Wound healing [safety of the device]
timeFrame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Paris
country: France
facility: APHP - Hôpital Tenon
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
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