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

Hyprevention

Status

Completed

Conditions

Vertebral Compression Fracture

Treatments

Device: V-STRUT

Study type

Interventional

Funder types

Industry

Identifiers

NCT03580434

SPINE0

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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