VCFix spinal implant to stabilize thoracic and lumbar vertebral compression fractures

A Prospective Multicenter Clinical Investigation Evaluating the Safety and Efficacy of the VCFix Spinal System in Stand-alone Configuration for Vertebral Augmentation (EXPAND)

This trial will try the VCFix spinal implant to reduce back pain and improve mobility in adults 21–85 with a single recent or reducible thoracic or lumbar vertebral compression fracture.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 103 (estimated)
• Ages: 21 Years to 85 Years
• Sex: All
• Sponsor: Amber Implants B.V. (industry)
• Locations: 3 sites (Chambéry and 2 other locations)
• Trial ID: NCT07301749 on ClinicalTrials.gov

What this trial studies

This interventional study implants the VCFix Spinal System in a stand-alone configuration in adults with a single thoracic or lumbar vertebral compression fracture. Eligible participants must meet imaging and clinical criteria (AO Type A compression fracture, fracture age under 6 weeks or radiographically reducible, 10–60% anterior or midbody height loss, and NPRS pain ≥5) and have suitable pedicle anatomy on CT/MRI. After implantation, patients will be followed with scheduled clinical assessments and imaging to track pain, physical function, mobility, vertebral height, and any device- or procedure-related adverse events. The primary goals are reduction in fracture-related pain and improvement in function and mobility while confirming the absence of device- or procedure-related serious adverse events.

Who should consider this trial

Good fit: Adults aged 21–85 with a single thoracic or lumbar AO Type A vertebral compression fracture (≤6 weeks old or radiographically reducible), 10–60% vertebral height loss, NPRS ≥5, suitable pedicle anatomy on preoperative CT/MRI, and considered a surgical candidate are ideal for this study.

Not a fit: Patients with multiple vertebral fractures, chronic unreducible fractures, fractures outside the thoracic/lumbar regions, unsuitable pedicle anatomy, very high surgical risk, or other contraindications are unlikely to receive benefit from this device in the trial.

Why it matters

Potential benefit: If successful, the VCFix implant could reduce fracture-related back pain, improve mobility and vertebral stability, and help patients recover function more quickly than nonoperative management.

How similar studies have performed: Other vertebral augmentation approaches such as vertebroplasty and kyphoplasty have shown pain relief and functional improvement in many studies, but VCFix is a newer device with limited published outcome data specific to its design.

Eligibility criteria

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 has a NPRS back pain score of ≥5
4. Subject is a candidate for surgical intervention based on investigator opinion
5. Subject has a body Mass Index (BMI) \< 35
6. Subject is mentally capable of complying with trial protocol requirements for the duration of the study
7. 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. Pre-existing vertebral fracture prior to the index fracture
6. Subjects that require anterior stabilization of the index fracture
7. Fracture to the pedicle based on radiographic evaluation
8. Spinal cord compression or canal compromise requiring decompression
9. Severe back pain due to causes other than acute fracture with NPRS score\>5
10. The subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
11. Pain due to any other condition that requires daily narcotic (opiates or opioids) medication
12. Pre-existing neurological deficit, radiculopathy or myelopathy
13. 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
14. Contraindications to both MRI and radionuclide bone scan
15. Concurrent participation in another clinical study which could potentially interfere with the outcome of this study.
16. A life expectancy less than the study duration or undergoing palliative care
17. Subject non-ambulatory prior to fracture
18. Allergy to any components of the device/instruments used during the procedure
19. Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection
20. Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfecta, Paget's disease, etc.)
21. Any evidence of alcohol or drug abuse.
22. Ongoing long-term steroid therapy (steroid dose ≥30 mg /day for \>3 months)
23. The subject is currently on anti-cancer therapy or anti-HIV therapy
24. Pregnancy or subjects with child-bearing potential that are unwilling to use contraception throughout the study duration

Where this trial is running

Chambéry and 2 other locations

• Centre Hospitalier Métropole de Savoie — Chambéry, France (NOT_YET_RECRUITING)
• Wilhelmsburger Krankenhaus Groß-Sand — Hamburg, Germany (RECRUITING)
• Krankenhaus Mechernich — Mechernich, Germany (RECRUITING)

Study contacts

• Study coordinator: Clinical Research Manager

Conditions: Vertebral Compression Fracture, VCF, EXPAND, vertebral stabilization, fracture, trauma, osteoporosis, expandable implant