An observational study in Vertebra Compression Fracture, sponsored by Amber Implants B.V.. Recruiting at 3 sites in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Amber Implants B.V. · Observational
This study is designed as a prospective, post-market, multi-center, single-arm study to collect real-world data of the VCFix Spinal System used in US clinical practice.
Approximately 5 centers in the US will enroll subjects with VCF in a non-randomized fashion, and VCFix will be used within its cleared purpose and indications for use.
The study has been designed to be methodologically compatible with the EU EXPAND (CIP-VS02-EU) study, thereby aiming for the pooling of data to the EU study. Data pooling will be pursued only as a sensitivity analysis if pre-specified similarity criteria are met. The US study provides meaningful real-world evidence regardless of pooling feasibility.
The targeted patient population, assessment schedule, and study endpoints are therefore similar to those of the EU EXPAND study.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 30 is below the median of 130 across 239 observational 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.
Adult patients undergoing treatment with the VCFix Spinal System as part of standard clinical care for vertebral compression fractures. The study will enroll patients treated according to routine clinical practice and will collect real-world evidence on clinical outcomes, radiographic outcomes, and patient-reported outcomes following treatment.
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.
Patients with a (suspected) diagnosis of severe osteoporosis and a single vertebral compression fracture
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 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.
Incidence of serious adverse events (SAEs) related to the device and/or investigational procedure (safety)
Incidence of serious adverse events (SAEs) related to the device and/or investigational procedure within 30 days post-procedure. This includes SAEs resulting from mechanical malfunction, structural compromise, device failure, or loss of intended function, as well as events representing deviations from the device's intended medical purpose.
Time frame: 1 month
Vertebral fracture-related pain as assessed by the Numeric Pain Rating Scale (NPRS)
Difference in vertebral fracture-related pain from baseline 6 months post procedure measured by the 11-point (0 = no pain, 10 is worst pain) Numerical Pain Rating Scale (NPRS).
Time frame: 6 months
Functional disability, measured by the Oswestry disability index (ODI)
Difference in functional disability, measured by the Oswestry disability index (ODI) (0-100 scale, where 0 is no disability and 100 is bed bound), from baseline to 6 months post procedure.
Time frame: 6 months
Vertebral height difference (anterior, midline, and posterior aspects)
Vertebral height difference (anterior, midline, and posterior aspects) at PO (Post-OP), 1M FU, 6M FU and 12M FU as compared to baseline.
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, 1 Month FU, 6 Months FU and 12 Months FU.
Vertebral fracture-related pain as assessed by the Numeric Pain Rating Scale (NPRS)
Difference in vertebral fracture-related pain from baseline to Discharge, 1, 3, 6 and 12 Months post procedure measured by the 11-point (0 = no pain, 10 is worst pain) Numerical Pain Rating Scale (NPRS).
Time frame: Discharge, 1, 3, 6 and 12 Months FU compared to baseline.
Functional disability, measured by the Oswestry disability index (ODI)
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
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.
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: Undecided
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jul 2027, 9 months after the start.
Of 86 observational studies under Fractures, Bone, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 124. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Amber Implants B.V.