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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-STRUT | Experimental | V-STRUT implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-STRUT | Device | Minimally invasive implantation of V-STRUT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | per-operative |
| Type of anaesthesia [feasibility of the procedure] | Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other. | per-operative |
| Cement quantity injected [feasibility of the procedure] | Record cement quantity injected in the vertebral body, in cc (cubic centimeter). | per-operative |
| Operating time [feasibility of the procedure] | Measuring the duration of the surgical procedures. | per-operative |
| Hospitalisation stay [feasibility of the procedure] | Measuring the duration of the hospitalisation stay. | per-operative and immediate post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Pain [performance of the device] | Self-evaluation of pain using Visual Analogue Scale (VAS) going from 0 (no pain) to 10 (maximum). | pre- operative, immediate post-op, at 2 months, 6 months and 12 months. |
| Frequencies of ADEs and SADEs [safety of the device] |
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Inclusion Criteria :
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | France | ||||
| APHP - Hôpital Tenon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28183325 | Background | Cornelis FH, Tselikas L, Carteret T, Lapuyade B, De Baere T, Le Huec JC, Deschamps F. Percutaneous internal fixation with Y-STRUT(R) device to prevent both osteoporotic and pathological hip fractures: a prospective pilot study. J Orthop Surg Res. 2017 Feb 9;12(1):27. doi: 10.1186/s13018-017-0514-2. | |
| 28757428 | Background |
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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.
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Measuring the frequencies of Adverse Device-related Events (ADEs) and Severe Adverse Device-related Events (SADEs). |
| 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. | 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. | 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. | 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. | 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. | per-operative, immediate post-op, at 2 months, 6 months and 12 months. |
| Paris |
| 75020 |
| France |
| Institut Gustave Roussy | Villejuif | France |
| Cornelis FH, Deschamps F. Augmented osteoplasty for proximal femur consolidation in cancer patients: Biomechanical considerations and techniques. Diagn Interv Imaging. 2017 Sep;98(9):645-650. doi: 10.1016/j.diii.2017.06.014. Epub 2017 Jul 27. |
| 28233056 | Background | Cornelis FH, Tselikas L, Carteret T, Lapuyade B, De Baere T, Cabane V, Rodrigues L, Maas C, Deschamps F. A Novel Implant for the Prophylactic Treatment of Impending Pathological Fractures of the Proximal Femur: Results from a Prospective, First-in-Man Study. Cardiovasc Intervent Radiol. 2017 Jul;40(7):1070-1076. doi: 10.1007/s00270-017-1613-5. Epub 2017 Feb 23. |
| Background | Szpalski M,Le Huec JC, Jayankura M, Reynders P, Maas C(2017) Contralateral Prophylactic Reinforcement in Case of First Low-Energy Hip Fracture: First-in-Man Clinical Data of a New Percutaneous Internal Fixation Device. J Osteopor Phys Act 5:202. doi:10.4172/2329-9509.100020 |
| 20098352 | Background | Upasani VV, Robertson C, Lee D, Tomlinson T, Mahar AT. Biomechanical comparison of kyphoplasty versus a titanium mesh implant with cement for stabilization of vertebral compression fractures. Spine (Phila Pa 1976). 2010 Sep 1;35(19):1783-8. doi: 10.1097/BRS.0b013e3181b7cc5d. |
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| 12427616 | Background | Belkoff SM, Mathis JM, Jasper LE. Ex vivo biomechanical comparison of hydroxyapatite and polymethylmethacrylate cements for use with vertebroplasty. AJNR Am J Neuroradiol. 2002 Nov-Dec;23(10):1647-51. |
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