Vertebra Compression FractureEXPAND-USNCT07920484
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
An observational study of Vertebra Compression Fracture, run by Amber Implants B.V. at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Vertebra Compression Fracture
- What is being tested?
- VCFix Spinal System in stand-alone configuration
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Oct 2026to 31 Dec 2028
- Phase
- Observational
- 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
Study population: 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.
Who may be able to join
- 1. Subject is ≥ 21 to ≤ 85 years old. 2.
- 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
- 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 3. Subject is diagnosed with, or has a suspected diagnosis of, severe osteoporosis, including low trabecular bone quality , and/or an oversized vertebral body as compared to implant size (e.g. relatively small pedicle requiring smaller implant size than desired for vertebral body size and/or fracture characteristics and location) 4. Subject has a NPRS back pain score of ≥5 5. Subject is a candidate for surgical intervention based on investigator opinion 6. Subject has a body Mass Index (BMI) < 35 7. Subject is mentally capable of complying with trial protocol requirements for the duration of the study 8. 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°
- Any pre-existing vertebral fracture prior to the index fracture
- Previous spine surgery, balloon kyphoplasty or vertebroplasty, for any vertebral fracture
Show all 30Show fewer
- Subjects that require anterior stabilization of the index fracture
- 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
- Irreversible coagulopathy or bleeding disorder
- Contraindications to both MRI and Computed Tomography (CT) imaging
- 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
- 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.
- Patient known to be involved in medical litigation including Workmen's Compensation prior to the surgery
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Montefiore Medical Center
New York, New York, 10467
Research Administrator, (718) 920-6202
- Not yet recruiting
University of Oklahoma Health Campus
Oklahoma City, Oklahoma, 73104
Research Project Manager, (405) 271-8001
- Not yet recruiting
Rothman Orthopaedics
Philadelphia, Pennsylvania, 19107
Clinical Research Coordinator, (484) 335-2910
About this study
Official title: A Prospective, Multicenter, Post-Market Clinical Study Collecting Real-World Data of the VCFix Spinal System in Stand-Alone Configuration for Vertebral Augmentation (EXPAND-US)
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.
Read more
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.
- Conditions
- Vertebra Compression Fracture
- Being tested
- VCFix Spinal System in stand-alone configuration
- Keywords
- VCF, EXPAND-US, vertebral stabilization, fracture, vertebral fracture, osteoporosis, expandable implant
- Medical subject headings
- Fractures, Bone, Spinal Fractures, 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: 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.
| Study group | Role | What they receive |
|---|---|---|
| Implant of the VCFix device per IFU | Patients with a (suspected) diagnosis of severe osteoporosis and a single vertebral compression fracture 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.
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.
Measured: 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).
Measured: 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.
Measured: 6 months
Secondary outcomes (7)
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.
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, 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).
Measured: 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.
Measured: 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)
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.
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 posted5 Nov 2026
- Study start4 Oct 2026
- Primary completion21 Jul 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebra 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT07920484
- Sponsor's protocol ID
- CIP-VS03-US
- Acronym
- EXPAND-US
- Status last verified
- Nov 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Post-Market Clinical Study Collecting Real-World Data of the VCFix Spinal System in Stand-Alone Configuration for Vertebral Augmentation (EXPAND-US)
- ClinicalTrials.gov ID
- NCT07920484
- Acronym / sponsor ID
- EXPAND-US / CIP-VS03-US
- Conditions
- Vertebra Compression Fracture
- Keywords
- VCF, EXPAND-US, vertebral stabilization, fracture, vertebral fracture, osteoporosis, expandable implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Amber Implants B.V.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2026 (actual)
- Primary completion
- 21 Jul 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Nov 2026 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant of the VCFix device per IFU | – | Device: VCFix Spinal System in stand-alone configurationPatients with a (suspected) diagnosis of severe osteoporosis and a single vertebral compression fracture |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 1. Subject is ≥ 21 to ≤ 85 years old. 2.
- 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
Key exclusion criteria (30 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°
- Any 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 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 | Implant of the VCFix device per IFU |
Primary outcome
Incidence of serious adverse events (SAEs) related to the device and/or investigational procedure (safety)
Time frame: 1 month
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.
Vertebral fracture-related pain as assessed by the Numeric Pain Rating Scale (NPRS)
Time frame: 6 months
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).
Functional disability, measured by the Oswestry disability index (ODI)
Time frame: 6 months
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.
7 secondary outcomes
Vertebral height difference (anterior, midline, and posterior aspects)
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, 1 Month FU, 6 Months FU and 12 Months FU.
Vertebral fracture-related pain as assessed by the Numeric 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)
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
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 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebra Compression Fracture, run by Amber Implants B.V. at 3 sites in United States.
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 7 inclusion and 30 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 5 Nov 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 United States. 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-US@amberimplants.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (SAEs) related to the device and/or investigational procedure (safety) (time frame: 1 month). 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 5 Nov 2026.