An interventional study of SpineJack system and Conservative management in Spinal Fractures, Vertebral Compression Fractures and Back Injuries, sponsored by Vexim SA. Completed at 9 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-04-20.
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 6th largest by enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2016, is one of 8 with no phase, and was the 7th 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: 18 Years to 60 Years · all sexes · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2016.
This study's enrollment of 100 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.
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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.
This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:
100 subjects (18 to 60 years old) will be enrolled (1:1) with one to two painful traumatic fractures, non-pathological (types A1 and A3.1 by Magerl Classification).
Subjects will be followed at admission, procedure, discharge, 1 month, 3 months, 12 months and 24 months post Vertebral Compression Fracture (VCF) reduction procedure or the set-up of the brace.
The estimated enrollment period is 12 months and each patient should perform a 24 months follow-up period. Therefore, the total study duration is estimated to be 36 months for the complete study.
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.
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.
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.
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.
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.
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.
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.
Spine fracture management
Device: SpineJack system
Surgical corset according to measurement's impression, rigid corset with sternal support
Device: Conservative management
Spine fracture management for traumatic vertebral compression fracture
Surgical corset according to measurement's impression, rigid corset with sternal support
VAS
Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up
Time frame: 1 and 12 months follow-up
Oswestry Disability Index
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
EQ-5D
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Kyphotic angle
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Regional Kyphotic Angle
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Evaluation of safety through evaluation of adverse events
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Costs comparison of overall treatments
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2016 to primary completion in May 2019, 40 months.
Of 36 interventional studies with no phase under Spinal Fractures, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 70. This study's 40 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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