An interventional study of Vertebral fracture surgery SpineJack® and Balloon Kyphoplasty in Spinal Fractures, Vertebral Compression Fractures and Back Injuries, sponsored by Vexim SA. Completed at 13 sites in 5 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Vexim SA (part of Stryker) · Not applicable, Interventional, and Treatment
Among 21 studies in Spinal Fractures with a site in France — 4 open to participants now, 5 under way, none of them phase 3. Spinal Fractures · France.
Among the 21 studies in Spinal Fractures with a site in France, this one is the 5th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2015, is one of 8 with no phase, and was the 6th registered.
144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.
Browse Spinal Fractures studies →4 of the 21 studies in Spinal Fractures with a site in France are open now. Recruiting first, the newest first:
University Hospital, Bordeaux · Sites in France
Ages 18+
Clariance · Sites in France
Ages 18+
Teknimed · Sites in France, Portugal, Spain and 1 more country
Ages 18+
Centre Hospitalier Universitaire de Nice · Sites in France
Ages 50+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 18 Spinal Fractures studies recruiting now, 11 (61%) set no upper age limit and 4 (22%) stop at 75 or younger; 2 take children under 18; none take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2015.
This study's enrollment of 152 is above the median of 85 across 85 interventional studies indexed under Spinal Fractures.
Median enrollment 93 across the 12 interventional studies, 150 across the 9 observational. Of the 15 that completed or were terminated, 3 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 21 have an industry lead sponsor. The 10 most frequent:
This study is registered under Vexim SA, one of the names counted as Stryker. Under that name alone:
Vexim SA is the lead sponsor of 2 studies on the registry; none are open to participants now.
Stryker has 3 studies filed under Spinal Fractures — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 21 studies in Spinal Fractures with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.
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.
1 painful VCF which at least meet all following criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VCF treatment system Vertebral fracture surgery
Device: Vertebral fracture surgery SpineJack®
VCF treatment system Vertebral fracture surgery
Procedure: Balloon Kyphoplasty
Vertebral augmentation for one osteoporotic vertebral compression fracture
Proportion of Participants With Study Success
The primary composite endpoint defines a successful subject if the following components are satisfied (safety and effectiveness): 1. Reduction in VCF fracture-related pain at 12 months from baseline as measured by a 100 mm VAS scale (reduction of pain at 12 months by \> 20 mm) AND, 2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) AND, 3. Absence of device-related serious adverse events, defined as device-related adverse events (device migration, recollapse, protrusion) or symptomatic cement extravasation requiring surgical re-intervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation.
Time frame: 12 month post-op
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Apr 2015, a primary completion of Feb 2018 and a completion of Feb 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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