Vertebral Compression FractureNCT03580434
The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System
A study testing V-STRUT in people with Vertebral Compression Fracture, run by Hyprevention at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Compression Fracture
- What is being tested?
- V-STRUT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Feb 2019to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Polyclinique Bordeaux Nord Aquitaine
Bordeaux
APHP - Hôpital Tenon
Paris, 75020
Institut Gustave Roussy
Villejuif
About this study
Official title: National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture 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.
- Conditions
- Vertebral Compression Fracture
- Being tested
- V-STRUT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-STRUTDevice
Minimally invasive implantation of V-STRUT
| Study group | Role | What they receive |
|---|---|---|
| V-STRUT | Experimental | V-STRUT implantation Receives: Device: V-STRUT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: per-operative
Type of anaesthesia [feasibility of the procedure]
Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other.
Measured: per-operative
Cement quantity injected [feasibility of the procedure]
Record cement quantity injected in the vertebral body, in cc (cubic centimeter).
Measured: per-operative
Operating time [feasibility of the procedure]
Measuring the duration of the surgical procedures.
Measured: per-operative
Hospitalisation stay [feasibility of the procedure]
Measuring the duration of the hospitalisation stay.
Measured: per-operative and immediate post-op
Secondary outcomes (7)
Pain [performance of the device]
Self-evaluation of pain using Visual Analogue Scale (VAS) going from 0 (no pain) to 10 (maximum).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start1 Feb 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Vertebral Compression FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyprevention
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580434
- Sponsor's protocol ID
- SPINE0
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2018
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 28183325Cornelis 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.
PubMed 28757428Cornelis 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.
PubMed 28233056Szpalski 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
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.
PubMed 20098352Ghofrani 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.
PubMed 20634659Belkoff 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.
PubMed 12427616Rodrigues 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.
PubMed 21481652Tutton 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.
PubMed 25822543Dohm 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.
PubMed 25300981Olivarez 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.
PubMed 25802677Wang 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.
PubMed 25794218Li 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.
PubMed 21423053Deschamps 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.
PubMed 22889809Kobayashi 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.
PubMed 19124098
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment
- ClinicalTrials.gov ID
- NCT03580434
- Acronym / sponsor ID
- SPINE0
- Conditions
- Vertebral Compression Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- HypreventionIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V-STRUT | Experimental | Device: V-STRUTV-STRUT implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-STRUTMinimally invasive implantation of V-STRUT | Device | V-STRUT |
Primary outcome
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.
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.
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.
7 secondary outcomes
Pain [performance of the device]
Time frame: pre- operative, immediate post-op, at 2 months, 6 months and 12 months.
Frequencies of ADEs and SADEs [safety of the device]
Time frame: per- operative, immediate post-op, at 2 months, 6 months and 12 months.
Rates of cement leakage [safety of the device]
Time frame: Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Rates of fractures [safety of the device]
Time frame: Per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Functional score [safety of the device]
Time frame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Haematomas and infections rates [safety of the device]
Time frame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Wound healing [safety of the device]
Time frame: per-operative, immediate post-op, at 2 months, 6 months and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 28183325Cornelis 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.
- Background: PubMed 28757428Cornelis 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.
- Background: PubMed 28233056Cornelis 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.
- BackgroundSzpalski 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
- Background: PubMed 20098352Upasani 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.
- Background: PubMed 20634659Ghofrani 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.
- Background: PubMed 12427616Belkoff 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.
- Background: PubMed 21481652Rodrigues 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.
- Background: PubMed 25822543Tutton 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.
- Background: PubMed 25300981Dohm 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.
- Background: PubMed 25802677Olivarez 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.
- Background: PubMed 25794218Wang 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-STRUT in people with Vertebral Compression Fracture, run by Hyprevention at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties of the procedure [feasibility of the procedure] (time frame: per-operative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03580434, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.