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. (EXPAND-US)

November 4, 2026 updated by: Amber Implants B.V.

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
          • Research Administrator
          • Phone Number: (718) 920-6202
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Not yet recruiting
        • University of Oklahoma Health Campus
        • Contact:
          • Research Project Manager
          • Phone Number: (405) 271-8001
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Rothman Orthopaedics
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: (484) 335-2910

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Neoplasms with posterior involvement and/or presence of a mass within the spinal canal

  2. 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).

  3. Spondylolisthesis > Grade 1 at target vertebral body(s)

  4. Local kyphotic angle > 30°

  5. Any pre-existing vertebral fracture prior to the index fracture

  6. Previous spine surgery, balloon kyphoplasty or vertebroplasty, for any vertebral fracture

  7. Subjects that require anterior stabilization of the index fracture

  8. Fracture to the pedicle based on radiographic evaluation

  9. Spinal cord compression or canal compromise requiring decompression

  10. Severe back pain due to causes other than acute fracture with NPRS score > 5

  11. The subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)

  12. Pain due to any other condition that requires daily narcotic (opiates or opioids) medication

  13. Pre-existing neurological deficit, radiculopathy or myelopathy

  14. Pre-existing condition or significant co-morbidity:

    1. Uncontrolled diabetes (HbA1c >8%)
    2. Severe cardiopulmonary deficiencies
    3. Any other condition that would impact study outcome in the opinion of the investigator

  15. Irreversible coagulopathy or bleeding disorder

  16. Contraindications to both MRI and Computed Tomography (CT) imaging

  17. Concurrent participation in another clinical study which could potentially interfere with the outcome of this study

  18. A life expectancy less than the study duration or undergoing palliative care

  19. Subject non-ambulatory prior to fracture Allergy to any components of the device/instruments used during the procedure

  20. Allergy to any components of the device/instruments used during the procedure

  21. Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection

  22. Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfecta, Paget's disease, etc.)

  23. Any evidence of alcohol or drug abuse

  24. Ongoing long-term steroid therapy (steroid dose ≥30 mg /day for >3 months)

  25. The subject is currently on anti-cancer therapy or anti-HIV therapy

  26. Pregnancy or subjects with child-bearing potential that are unwilling to use contraception throughout the study duration.

  27. Patient known to be involved in medical litigation including Workmen's Compensation prior to the surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Implant of the VCFix device per IFU

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 month
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).
6 months
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vertebral height difference (anterior, midline, and posterior aspects)
Time Frame: Post-Operative, 1Month FU, 6 Months FU, 12 Months FU

Vertebral height difference (anterior, midline, and posterior aspects) at PO (Post-OP), 1M FU, 6M FU and 12M FU as compared to baseline.
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.

Kyphotic angle and Cobb angle improvement
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.

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).
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

Improvement in function (measured by the 100-point Oswestry Disability Index (ODI)) at discharge, 1, 3, 6 and 12 months FU compared to baseline.
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

Improvement of Health-related quality of life (HRQoL)
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

Device-related serious adverse events
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

All (per protocol reportable) adverse events assessed at 12- and 24- months post-procedure.
12 Months FU, 24 Months FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amber Implants B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-VS03-US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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