An interventional study of VCFix Spinal System in stand-alone configuration in Vertebral Compression Fracture, sponsored by Amber Implants B.V.. Recruiting at 3 sites in 2 countries. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Amber Implants B.V. · Not applicable, Interventional, and Treatment
This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults.
Up to 8 hospitals in Europe will take part in the study. All participants will receive treatment with the VCFix device. The treatment will be provided according to the intended use of the device and may be performed either with or without the use of a special bone cement.
Participants will be assigned to one of two study groups before treatment:
Cementless group: the VCFix device is implanted without bone cement. Cemented group: the VCFix device is implanted together with bone cement.
The study will assess how well the treatment works and how safe it is. Researchers will evaluate:
Changes in back pain 6 months after treatment compared with before treatment. Changes in daily functioning and ability to perform everyday activities 6 months after treatment compared with before treatment.
Whether any serious device-related complications occur during the first month after treatment.
The results will help determine whether treatment with the VCFix device provides benefits for patients with vertebral compression fractures while maintaining an acceptable safety profile.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 148 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Amber Implants B.V. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Single vertebral fracture which meets all of the following criteria:
Exclusion Criteria:
Pre-existing condition or significant co-morbidity:
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.
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.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implant of the VCFix device with the use of PMMA bone cement
Device: VCFix Spinal System in stand-alone configuration
Implant of the VCFix device without the use of PMMA bone cement
Device: VCFix Spinal System in stand-alone configuration
The distinguishing features of this inetrvention reside in: 1. In situ adjustment and maintenance of the height and angle of the device that allows expansion of the fractured VB in the cranio-caudal direction to realign the vertebral endplates and correct kyphosis. 2. The complex titanium perforated structure with optimized surface roughness that allows possible bone attachment, thereby permitting natural healing of the bone and potentially providing more stability to the device and the treated vertebra over time. 3. The ability to likely secure and reinforce the vertebra without using PMMA bone cement, avoiding all the symptomatic and asymptomatic side effects of bone cement. 4. The ability to connect the posterior to the anterior column of the spine through the pedicle screw component of the VCFix implant, therefore improving the biomechanical load distribution and consequently the ability to stabilize more severe fractures.
Reduction of more than 2 points in vertebral fracture-related pain intensity at 6 months after the index procedure compared to baseline as measured by a 11-point Numerical Pain Rating Scale (NPRS)
Time frame: 6 months
Maintenance or improvement of function as measured by the 100-point Oswestry Disability Index (ODI) at 6 months compared to baseline
Time frame: 6 months
Absence of serious adverse device effects (SADEs): No SADEs with causality rated as definite, monitored through 1 month post-procedure (safety)
Time frame: 1 month
Vertebral height restoration (anterior, midline, and posterior aspects) at PO (Post-Operative), 1Months FU, 6 Months FU and 12Months FU.
Time frame: Post-Operative, 1Month FU, 6 Months FU, 12 Months FU
Kyphotic angle and Cobb angle improvement at Post-Operative, 1 Month FU, 6 Months FU and 12 Months FU.
Kyphotic angle and Cobb angle improvement
Time frame: Post-Operative, ost-Operative, 1 Month FU, 6 Months FU and 12 Months FU.
Reduction in vertebral fracture-related pain (measured by the 11-point Numerical Pain Rating Scale (NPRS))
Reduction in vertebral fracture-related pain
Time frame: Discharge, 1, 3, 6 and 12 Months FU compared to baseline.
Improvement in function (measured by the 100-point Oswestry Disability Index (ODI)) at discharge, 1, 3, 6 and 12 months FU compared to baseline.
Time frame: Discharge, 1, 3, 6 and 12 months FU
Improvement of Health-related quality of life (HRQoL) measured by EuroQol 5-Dimension Scale (EQ-5D-5L) at 1 Month, 3 Months, 6 Months and 12 Months post-procedure compared to baseline
Improvement of Health-related quality of life (HRQoL)
Time frame: 1 Month, 3 Months, 6 Months and 12 Months post-procedure compared to baseline
Device-related serious adverse events assessed at 12- and 24- months post-procedure.
Device-related serious adverse events
Time frame: 12 months FU, 24 months FU
All (per protocol reportable) adverse events assessed at 12- and 24- months post-procedure.
Time frame: 12 Months FU, 24 Months FU
Plan to share: No
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Amber Implants B.V.