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Vertebral Compression FractureNCT07259811

Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration

A study testing VCFix Spinal System in stand-alone configuration in people with Vertebral Compression Fracture, run by Amber Implants B.V. at 2 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and works well in early testings, so that a larger safety study can be done later to help get… Read more about this study

Who is it for?
Ages 22 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
10 participants
Where
2 sitesGermany
Study dates
18 Sep 2023to 30 Sep 2026
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 22 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female between 22 and 85 years of age
  • One (single) vertebral fracture which meets all the following criteria:
  • Type A fractures as defined by the AO spine classification (compression injuries)1
  • 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 70% 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 Patient has a Numerical Pain Rating Scale (NPRS) back pain score of ≥5
  • Patient has an Oswestry Disability Index (ODI) score of ≥30/100
  • Patient has a BMI <35
  • Patient is mentally capable of complying with trial protocol requirements for the duration of the study
  • Patient can understand the risks and benefits of participating in the study and can provide written informed consent
  • Patient is available for all study visits

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 oedema or fluid or empty cleft are not visible in radiographic imaging, or fracture mode does not allow for fracture reduction in craniocaudal direction) 2
  • Vertebral fracture prior to the incident fracture
  • Fracture to the pedicle based on radiographic evaluation
  • Asymptomatic vertebral fractures
  • Patient clearly improving with pharmacological treatment
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  • Previous spine surgery, balloon kyphoplasty or vertebroplasty, for any vertebral fracture
  • Spinal cord compression or canal compromise requiring decompression
  • Severe back pain due to causes other than acute fracture with NPRS score > 5
  • Pain due to any other condition that requires daily narcotic medication
  • Pre-existing neurological deficit, radiculopathy or myelopathy
  • Significant clinical comorbidity that the enrolling physician considers may either contraindicate surgery or interfere with long-term data collection or follow-up
  • Pre-existing conditions such as:
  • Allergy to any components of the device/instruments used during the procedure or to PMMA bone cement
  • Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection
  • Irreversible coagulopathy or bleeding disorder
  • Uncontrolled diabetes (HbA1c >8%)
  • Severe cardiopulmonary deficiencies
  • Contraindications to MRI or radionuclide bone scan
  • Concurrent participation in any other clinical study for which the primary outcomes are not achieved
  • A life expectancy less than the study duration or undergoing palliative care
  • Patient non-ambulatory prior to fracture
  • Spondylolisthesis >Grade 1 at target vertebral body(s)
  • Local kyphotic angle >30°
  • Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.)
  • The patient has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
  • Any evidence of substance use disorder (alcohol, drugs)
  • Ongoing long-term steroid therapy (steroid dose ≥30 mg /day for > 3 months)
  • The patient is currently on anti-cancer therapy or anti-HIV therapy
  • Patient known to be involved in medical litigation including Workmen's Compensation prior to the surgery
  • Pregnancy or patients with child-bearing potential who do not accept taking contraception throughout the study duration
  • Patients who require anterior stabilisation

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Wilhelmsburger Krankenhaus Groβ-Sand

    Hamburg, 21107

  • Krankenhaus Mechernich

    Mechernich, 53894

Other trials in Germany

About this study

This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and works well in early testings, so that a larger safety study can be done later to help get CE approval. The VCFix Spinal System will be used in its independent setup, within its planned use for treatment of vertebral compression fracture. It's designed to be a small early study to test safety and see if the treatment idea is possible, with one group and no blinding. Two hospitals in EU will enroll in total 10 participants with a single vertebral fracture that will undergo the same surgery.

The main test goals are: how successful the access creation of the vertebral body is using the VCFix Preparation kit according to the provided instructions, how successful the positioning of the VCFix implant is by using the VCFix Implantation kit according to the provided instructions, and how successful the fracture reduction by expanding the VCFix implant according to the provided instructions. The main safety goal is: number of device-/procedure-related major side effects through 30 days after the initial procedure.

Participant enrollment will last around 12 months. Each participant will be followed for 2 years after the implantations. All side effects related to the spine will be documented throughout the study.

Being tested
VCFix Spinal System in stand-alone configuration
Keywords
VCF, FIH, 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 intervention 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.

Study groups in NCT07259811
Study groupRoleWhat they receive
VCFix Spinal SystemExperimentalNot described
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.

  1. Outcome measure

    Rate of successful vertebral body access creation through use of the VCFix Preparation kit according to the provided labelling

    Measured: 2 years

  2. Outcome measure

    Rate of successful positioning of the VCFix implant through use of the VCFix Implantation kit according to the provided labelling

    Measured: 2 years

  3. Outcome measure

    Rate of successful fracture reduction by expansion of the VCFix implant according to the provided labelling

    Measured: 2 years

  4. Outcome measure

    Number of device-/procedure-related serious adverse events

    Measured: 30 days after index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start18 Sep 2023
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07259811
Sponsor's protocol ID
CIP-VS01-EU
Status last verified
Jun 2026
First submitted
21 Nov 2025
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 2 sites in Germany.

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 32 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: under way, not looking for participants, as of the sponsor's last update on 17 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 2 sites in Germany. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Outcome measure (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07259811.

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 17 Jun 2026.

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