Vertebral Compression FractureEXPANDNCT07301749
A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures
A study testing VCFix Spinal System in stand-alone configuration in people with Vertebral Compression Fracture, run by Amber Implants B.V. at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Vertebral Compression Fracture
- What is being tested?
- VCFix Spinal System in stand-alone configuration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Nov 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 21 to ≤ 85 years old.
- Single vertebral fracture which meets all of the following criteria:
- Type A fractures from AO spine classification (compression injuries);
- Vertebral fracture located in the thoracic and lumbar regions of the spine
- Fracture age < 6 weeks or fractures with anatomic signs of reducibility (based on radiographic evidence as well as patient history)
- Vertebral fracture shows an estimated height loss in the anterior or mid third of the vertebral body (VB) of at least 10% but not more than 60% based on radiographic evidence
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- Target VB has appropriate anatomy, i.e. suitable pedicle diameter, pedicle length and chord length that would allow for selection of correct implant size, as described in the IFU and based on axial MRI/CT scan before surgery
- Subject has a NPRS back pain score of ≥5
- Subject is a candidate for surgical intervention based on investigator opinion
- Subject has a body Mass Index (BMI) < 35
- Subject is mentally capable of complying with trial protocol requirements for the duration of the study
- Subject can understand the risks and benefits of participating in the study and is able to provide written informed consent
Who cannot join
- Neoplasms with posterior involvement and/or presence of a mass within the spinal canal
- Non-mobile fractures (i.e., fracture is not recent (>6 weeks), bone marrow edema or fluid or empty cleft are not visible in radiographic imaging, or fracture mode does not allow for fracture reduction in craniocaudal direction).
- Spondylolisthesis > Grade 1 at target vertebral body(s)
- Local kyphotic angle > 30°
- Pre-existing vertebral fracture prior to the index fracture
- Subjects that require anterior stabilization of the index fracture
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- Fracture to the pedicle based on radiographic evaluation
- Spinal cord compression or canal compromise requiring decompression
- Severe back pain due to causes other than acute fracture with NPRS score>5
- The subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
- Pain due to any other condition that requires daily narcotic (opiates or opioids) medication
- Pre-existing neurological deficit, radiculopathy or myelopathy
- Pre-existing condition or significant co-morbidity:
- Uncontrolled diabetes (HbA1c >8%)
- Severe cardiopulmonary deficiencies
- Any other condition that would impact study outcome in the opinion of the investigator
- Contraindications to both MRI and radionuclide bone scan
- Concurrent participation in another clinical study which could potentially interfere with the outcome of this study.
- A life expectancy less than the study duration or undergoing palliative care
- Subject non-ambulatory prior to fracture
- Allergy to any components of the device/instruments used during the procedure
- Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection
- Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfecta, Paget's disease, etc.)
- Any evidence of alcohol or drug abuse.
- Ongoing long-term steroid therapy (steroid dose ≥30 mg /day for >3 months)
- The subject is currently on anti-cancer therapy or anti-HIV therapy
- Pregnancy or subjects with child-bearing potential that are unwilling to use contraception throughout the study duration
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
Wilhelmsburger Krankenhaus Groß-Sand
Hamburg
Neurosurgery Department, +49 40 75 205, sprechstunde@gross-sand.de
- Recruiting
Krankenhaus Mechernich
Mechernich
Orthopaedic Department, +49 2443 170, ortho-ambulanz@kkhm.de
France1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Métropole de Savoie
Chambéry
Unité de Recherche Clinique, Dr., +33 4 79 96 50 30, info@ch-metropole-savoie.fr
About this study
Official title: A Prospective Multicenter Clinical Investigation Evaluating the Safety and Efficacy of the VCFix Spinal System in Stand-alone Configuration for Vertebral Augmentation (EXPAND)
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.
Read more
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.
- Conditions
- Vertebral Compression Fracture
- Being tested
- VCFix Spinal System in stand-alone configuration
- Keywords
- VCF, EXPAND, vertebral stabilization, fracture, trauma, osteoporosis, expandable implant
- Medical subject headings
- Fractures, Bone, Wounds and Injuries, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCFix Spinal System in stand-alone configurationDevice
The distinguishing features of this inetrvention reside in:
- 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.
- 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.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cemented cohort | Experimental | Implant of the VCFix device with the use of PMMA bone cement Receives: Device: VCFix Spinal System in stand-alone configuration |
| Uncemented cohort | Experimental | Implant of the VCFix device without the use of PMMA bone cement Receives: Device: VCFix Spinal System in stand-alone configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Maintenance or improvement of function as measured by the 100-point Oswestry Disability Index (ODI) at 6 months compared to baseline
Measured: 6 months
Absence of serious adverse device effects (SADEs): No SADEs with causality rated as definite, monitored through 1 month post-procedure (safety)
Measured: 1 month
Secondary outcomes (7)
Vertebral height restoration (anterior, midline, and posterior aspects) at PO (Post-Operative), 1Months FU, 6 Months FU and 12Months FU.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 12 months FU, 24 months FU
All (per protocol reportable) adverse events assessed at 12- and 24- months post-procedure.
Measured: 12 Months FU, 24 Months FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start4 Nov 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study comprises two predefined cohorts, assigned based on protocol-specific criteria applied prior to treatment: * a cementless cohort, where the device is implanted without polymethylmethacrylate (PMMA) bone cement * a cemented cohort, where the device is used in conjunction with PMMA bone cement Outcomes for each cohort will be evaluated independently against an external control. No direct comparison between the study cohorts is planned.
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amber Implants B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301749
- Sponsor's protocol ID
- CIP-VS02-EU
- Acronym
- EXPAND
- Status last verified
- Jun 2026
- First submitted
- 19 May 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Clinical Investigation Evaluating the Safety and Efficacy of the VCFix Spinal System in Stand-alone Configuration for Vertebral Augmentation (EXPAND)
- ClinicalTrials.gov ID
- NCT07301749
- Acronym / sponsor ID
- EXPAND / CIP-VS02-EU
- Conditions
- Vertebral Compression Fracture
- Keywords
- VCF, EXPAND, vertebral stabilization, fracture, trauma, osteoporosis, expandable implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Amber Implants B.V.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Dec 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study comprises two predefined cohorts, assigned based on protocol-specific criteria applied prior to treatment: * a cementless cohort, where the device is implanted without polymethylmethacrylate (PMMA) bone cement * a cemented cohort, where the device is used in conjunction with PMMA bone cement Outcomes for each cohort will be evaluated independently against an external control. No direct comparison between the study cohorts is planned.
| Arm | Type | Receives |
|---|---|---|
| Cemented cohort | Experimental | Device: VCFix Spinal System in stand-alone configurationImplant of the VCFix device with the use of PMMA bone cement |
| Uncemented cohort | Experimental | Device: VCFix Spinal System in stand-alone configurationImplant of the VCFix device without the use of PMMA bone cement |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is ≥ 21 to ≤ 85 years old.
- Single vertebral fracture which meets all of the following criteria:
- Subject has a NPRS back pain score of ≥5
- Subject is a candidate for surgical intervention based on investigator opinion
- Subject has a body Mass Index (BMI) < 35
Key exclusion criteria (27 listed)
- Neoplasms with posterior involvement and/or presence of a mass within the spinal canal
- Non-mobile fractures (i.e., fracture is not recent (>6 weeks), bone marrow edema or fluid or empty cleft are not visible in radiographic imaging, or fracture mode does not allow for fracture reduction in craniocaudal direction).
- Spondylolisthesis > Grade 1 at target vertebral body(s)
- Local kyphotic angle > 30°
- Pre-existing vertebral fracture prior to the index fracture
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 |
|---|---|---|
| VCFix Spinal System in stand-alone configurationThe 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. | Device | Cemented cohort, Uncemented cohort |
Primary outcome
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
7 secondary outcomes
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.
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))
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
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VCFix Spinal System in stand-alone configuration in people with Vertebral Compression Fracture, run by Amber Implants B.V. at 3 sites in 2 countries.
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 12 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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 Germany, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Manager (+31 15 200 2151, expand@amberimplants.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.