National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vertebral Compression Fracture
- Sponsor
- Hyprevention
- Enrollment
- 9
- Locations
- 3
- Primary Endpoint
- Difficulties of the procedure [feasibility of the procedure]
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Difficulties of the procedure [feasibility of the procedure]
Time Frame: 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]
Time Frame: per-operative
Record cement quantity injected in the vertebral body, in cc (cubic centimeter).
Operating time [feasibility of the procedure]
Time Frame: per-operative
Measuring the duration of the surgical procedures.
Hospitalisation stay [feasibility of the procedure]
Time Frame: per-operative and immediate post-op
Measuring the duration of the hospitalisation stay.
Type of anaesthesia [feasibility of the procedure]
Time Frame: per-operative
Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other.
Secondary Outcomes
- Rates of cement leakage [safety of the device](Per-operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Pain [performance of the device](pre- operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Functional score [safety of the device](per-operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Rates of fractures [safety of the device](Per-operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Frequencies of ADEs and SADEs [safety of the device](per- operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Haematomas and infections rates [safety of the device](per-operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Wound healing [safety of the device](per-operative, immediate post-op, at 2 months, 6 months and 12 months.)