search
Back to results

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

Primary Purpose

Vertebral Compression Fracture

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
V-STRUT
Sponsored by
Hyprevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Compression Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Polyclinique Bordeaux Nord Aquitaine
  • APHP - Hôpital Tenon
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

V-STRUT

Arm Description

V-STRUT implantation

Outcomes

Primary Outcome Measures

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.
Type of anaesthesia [feasibility of the procedure]
Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other.
Cement quantity injected [feasibility of the procedure]
Record cement quantity injected in the vertebral body, in cc (cubic centimeter).
Operating time [feasibility of the procedure]
Measuring the duration of the surgical procedures.
Hospitalisation stay [feasibility of the procedure]
Measuring the duration of the hospitalisation stay.

Secondary Outcome Measures

Pain [performance of the device]
Self-evaluation of pain using Visual Analogue Scale (VAS) going from 0 (no pain) to 10 (maximum).
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).
Rates of cement leakage [safety of the device]
Measuring the rates of cement leakages.
Rates of fractures [safety of the device]
Measuring the rates of subsequent, adjacent and pedicle fractures.
Functional score [safety of the device]
Measuring patient's disability using the 100 points ODI (Oswestry Disability Index) functional score.
Haematomas and infections rates [safety of the device]
Measuring haematomas and infections rates.
Wound healing [safety of the device]
Assessment of wound-healing by practitioners.

Full Information

First Posted
June 4, 2018
Last Updated
August 1, 2022
Sponsor
Hyprevention
search

1. Study Identification

Unique Protocol Identification Number
NCT03580434
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hyprevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Compression Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V-STRUT
Arm Type
Experimental
Arm Description
V-STRUT implantation
Intervention Type
Device
Intervention Name(s)
V-STRUT
Intervention Description
Minimally invasive implantation of V-STRUT
Primary Outcome Measure Information:
Title
Difficulties of the procedure [feasibility of the procedure]
Description
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
Title
Type of anaesthesia [feasibility of the procedure]
Description
Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other.
Time Frame
per-operative
Title
Cement quantity injected [feasibility of the procedure]
Description
Record cement quantity injected in the vertebral body, in cc (cubic centimeter).
Time Frame
per-operative
Title
Operating time [feasibility of the procedure]
Description
Measuring the duration of the surgical procedures.
Time Frame
per-operative
Title
Hospitalisation stay [feasibility of the procedure]
Description
Measuring the duration of the hospitalisation stay.
Time Frame
per-operative and immediate post-op
Secondary Outcome Measure Information:
Title
Pain [performance of the device]
Description
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.
Title
Frequencies of ADEs and SADEs [safety of the device]
Description
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.
Title
Rates of cement leakage [safety of the device]
Description
Measuring the rates of cement leakages.
Time Frame
Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Title
Rates of fractures [safety of the device]
Description
Measuring the rates of subsequent, adjacent and pedicle fractures.
Time Frame
Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Title
Functional score [safety of the device]
Description
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.
Title
Haematomas and infections rates [safety of the device]
Description
Measuring haematomas and infections rates.
Time Frame
per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Title
Wound healing [safety of the device]
Description
Assessment of wound-healing by practitioners.
Time Frame
per-operative, immediate post-op, at 2 months, 6 months and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
Country
France
Facility Name
APHP - Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
28183325
Citation
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.
Results Reference
background
PubMed Identifier
28757428
Citation
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.
Results Reference
background
PubMed Identifier
28233056
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
20098352
Citation
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.
Results Reference
background
PubMed Identifier
20634659
Citation
Ghofrani H, Nunn T, Robertson C, Mahar A, Lee Y, Garfin S. An evaluation of fracture stabilization comparing kyphoplasty and titanium mesh repair techniques for vertebral compression fractures: is bone cement necessary? Spine (Phila Pa 1976). 2010 Jul 15;35(16):E768-73. doi: 10.1097/BRS.0b013e3181d260bf.
Results Reference
background
PubMed Identifier
12427616
Citation
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.
Results Reference
background
PubMed Identifier
21481652
Citation
Rodrigues DC, Ordway NR, Ma CR, Fayyazi AH, Hasenwinkel JM. An ex vivo exothermal and mechanical evaluation of two-solution bone cements in vertebroplasty. Spine J. 2011 May;11(5):432-9. doi: 10.1016/j.spinee.2011.02.012. Epub 2011 Apr 11.
Results Reference
background
PubMed Identifier
25822543
Citation
Tutton SM, Pflugmacher R, Davidian M, Beall DP, Facchini FR, Garfin SR. KAST Study: The Kiva System As a Vertebral Augmentation Treatment-A Safety and Effectiveness Trial: A Randomized, Noninferiority Trial Comparing the Kiva System With Balloon Kyphoplasty in Treatment of Osteoporotic Vertebral Compression Fractures. Spine (Phila Pa 1976). 2015 Jun 15;40(12):865-75. doi: 10.1097/BRS.0000000000000906.
Results Reference
background
PubMed Identifier
25300981
Citation
Dohm M, Black CM, Dacre A, Tillman JB, Fueredi G; KAVIAR investigators. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2014 Dec;35(12):2227-36. doi: 10.3174/ajnr.A4127. Epub 2014 Oct 9.
Results Reference
background
PubMed Identifier
25802677
Citation
Olivarez LM, Dipp JM, Escamilla RF, Bajares G, Perez A, Stubbs HA, Block JE. Vertebral augmentation treatment of painful osteoporotic compression fractures with the Kiva VCF Treatment System. SAS J. 2011 Dec 1;5(4):114-9. doi: 10.1016/j.esas.2011.06.001. eCollection 2011.
Results Reference
background
PubMed Identifier
25794218
Citation
Wang CH, Ma JZ, Zhang CC, Nie L. Comparison of high-viscosity cement vertebroplasty and balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Pain Physician. 2015 Mar-Apr;18(2):E187-94.
Results Reference
background
PubMed Identifier
21423053
Citation
Li X, Yang H, Tang T, Qian Z, Chen L, Zhang Z. Comparison of kyphoplasty and vertebroplasty for treatment of painful osteoporotic vertebral compression fractures: twelve-month follow-up in a prospective nonrandomized comparative study. J Spinal Disord Tech. 2012 May;25(3):142-9. doi: 10.1097/BSD.0b013e318213c113.
Results Reference
background
PubMed Identifier
22889809
Citation
Deschamps F, de Baere T. Cementoplasty of bone metastases. Diagn Interv Imaging. 2012 Sep;93(9):685-689. doi: 10.1016/j.diii.2012.06.009. Epub 2012 Aug 11.
Results Reference
background
PubMed Identifier
19124098
Citation
Kobayashi N, Numaguchi Y, Fuwa S, Uemura A, Matsusako M, Okajima Y, Ishiyama M, Takahashi O. Prophylactic vertebroplasty: cement injection into non-fractured vertebral bodies during percutaneous vertebroplasty. Acad Radiol. 2009 Feb;16(2):136-43. doi: 10.1016/j.acra.2008.05.005.
Results Reference
background
PubMed Identifier
24077200
Citation
Otten LA, Bornemnn R, Jansen TR, Kabir K, Pennekamp PH, Wirtz DC, Stuwe B, Pflugmacher R. Comparison of balloon kyphoplasty with the new Kiva(R) VCF system for the treatment of vertebral compression fractures. Pain Physician. 2013 Sep-Oct;16(5):E505-12.
Results Reference
background
PubMed Identifier
26630417
Citation
Yang EZ, Xu JG, Huang GZ, Xiao WZ, Liu XK, Zeng BF, Lian XF. Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study. Spine (Phila Pa 1976). 2016 Apr;41(8):653-60. doi: 10.1097/BRS.0000000000001298.
Results Reference
background
PubMed Identifier
23407406
Citation
Korovessis P, Vardakastanis K, Repantis T, Vitsas V. Balloon kyphoplasty versus KIVA vertebral augmentation--comparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study. Spine (Phila Pa 1976). 2013 Feb 15;38(4):292-9. doi: 10.1097/BRS.0b013e31826b3aef. Erratum In: Spine (Phila Pa 1976). 2013 Nov 1;38(23):E1506.
Results Reference
background
PubMed Identifier
16983458
Citation
Shindle MK, Gardner MJ, Koob J, Bukata S, Cabin JA, Lane JM. Vertebral height restoration in osteoporotic compression fractures: kyphoplasty balloon tamp is superior to postural correction alone. Osteoporos Int. 2006 Dec;17(12):1815-9. doi: 10.1007/s00198-006-0195-x. Epub 2006 Sep 16.
Results Reference
background
PubMed Identifier
25884343
Citation
Liu JT, Li CS, Chang CS, Liao WJ. Long-term follow-up study of osteoporotic vertebral compression fracture treated using balloon kyphoplasty and vertebroplasty. J Neurosurg Spine. 2015 Jul;23(1):94-8. doi: 10.3171/2014.11.SPINE14579. Epub 2015 Apr 17.
Results Reference
background
PubMed Identifier
26109687
Citation
Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.
Results Reference
background
PubMed Identifier
24315046
Citation
Chen D, An ZQ, Song S, Tang JF, Qin H. Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. 2014 Mar;21(3):473-7. doi: 10.1016/j.jocn.2013.05.017. Epub 2013 Aug 8.
Results Reference
background
PubMed Identifier
23696683
Citation
Comstock BA, Sitlani CM, Jarvik JG, Heagerty PJ, Turner JA, Kallmes DF. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. 2013 Oct;269(1):224-31. doi: 10.1148/radiol.13120821. Epub 2013 May 21.
Results Reference
background
PubMed Identifier
24945287
Citation
Tan HY, Wang LM, Zhao L, Liu YL, Song RP. A prospective study of percutaneous vertebroplasty for chronic painful osteoporotic vertebral compression fracture. Pain Res Manag. 2015 Jan-Feb;20(1):e8-e11. doi: 10.1155/2015/181487. Epub 2014 Jun 19.
Results Reference
background
PubMed Identifier
21939548
Citation
Korovessis P, Repantis T, Miller LE, Block JE. Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: a case series of 26 consecutive patients. BMC Musculoskelet Disord. 2011 Sep 22;12:206. doi: 10.1186/1471-2474-12-206.
Results Reference
background
PubMed Identifier
24287674
Citation
Yi X, Lu H, Tian F, Wang Y, Li C, Liu H, Liu X, Li H. Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg. 2014 Jan;134(1):21-30. doi: 10.1007/s00402-013-1886-3. Epub 2013 Nov 28.
Results Reference
background
PubMed Identifier
23804157
Citation
Vogl TJ, Pflugmacher R, Hierholzer J, Stender G, Gounis M, Wakhloo A, Fiebig C, Hammerstingl R. Cement directed kyphoplasty reduces cement leakage as compared with vertebroplasty: results of a controlled, randomized trial. Spine (Phila Pa 1976). 2013 Sep 15;38(20):1730-6. doi: 10.1097/BRS.0b013e3182a14d15.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs