An interventional study of V-STRUT in Vertebral Compression Fracture, sponsored by Hyprevention. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Hyprevention · Not applicable, Interventional, and Treatment
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.
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's enrollment of 9 is below the median of 73 across 32 interventional studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →Hyprevention is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
V-STRUT implantation
Device: V-STRUT
Minimally invasive implantation of V-STRUT
Difficulties of the procedure [feasibility of the procedure]
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.
Time frame: per-operative
Type of anaesthesia [feasibility of the procedure]
Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other.
Time frame: per-operative
Cement quantity injected [feasibility of the procedure]
Record cement quantity injected in the vertebral body, in cc (cubic centimeter).
Time frame: per-operative
Operating time [feasibility of the procedure]
Measuring the duration of the surgical procedures.
Time frame: per-operative
Hospitalisation stay [feasibility of the procedure]
Measuring the duration of the hospitalisation stay.
Time frame: per-operative and immediate post-op
Pain [performance of the device]
Self-evaluation of pain using Visual Analogue Scale (VAS) going from 0 (no pain) to 10 (maximum).
Time frame: pre- operative, immediate post-op, at 2 months, 6 months and 12 months.
Frequencies of ADEs and SADEs [safety of the device]
Measuring the frequencies of Adverse Device-related Events (ADEs) and Severe Adverse Device-related Events (SADEs).
Time frame: per- operative, immediate post-op, at 2 months, 6 months and 12 months.
Rates of cement leakage [safety of the device]
Measuring the rates of cement leakages.
Time frame: Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Rates of fractures [safety of the device]
Measuring the rates of subsequent, adjacent and pedicle fractures.
Time frame: Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Functional score [safety of the device]
Measuring patient's disability using the 100 points ODI (Oswestry Disability Index) functional score.
Time frame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Haematomas and infections rates [safety of the device]
Measuring haematomas and infections rates.
Time frame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Wound healing [safety of the device]
Assessment of wound-healing by practitioners.
Time frame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Plan to share: Yes — The data analysis of the investigation will carry out a final report that will be sent to the CPP and ANSM. According to the law N°2002-303 dated March 4, 2002, the patients involved in the study will be informed on demand on the global data analysis. Regarding publication, if the data analysis provides important and interesting information on the device and its associated procedure for the treatment of vertebral compression fracture which aims to complete the state of the art, it may be decided to publish the corresponding data. In this case, the IPD that will be shared will consists of all IPD that underlie results in this publication.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Hyprevention