A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures. (EXPAND)

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

The primary objective of the EXPAND clinical investigation is to evaluate the safety and efficacy of the VCFix Spinal System for the treatment of Vertebral Compression Fractures. The study aims to demonstrate a reduction in vertebral fracture-related pain and an improvement in physical function and mobility, while ensuring the absence of (serious) adverse events ((S)AE) related to the device or procedure.

Study Overview

• Status: Recruiting
• Conditions: Vertebral Compression Fracture
• Intervention / Treatment: Device: VCFix Spinal System in stand-alone configuration

• Study Type: Interventional
• Enrollment (Estimated): 103
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Manager; Phone Number: +31 15 200 2151; Email: expand@amberimplants.com

Study Locations

• France
  • Chambéry, France
    • Not yet recruiting
    • Centre Hospitalier Métropole de Savoie
    • Contact: Unité de Recherche Clinique, Dr.; Phone Number: +33 4 79 96 50 30; Email: info@ch-metropole-savoie.fr
• Germany
  • Hamburg, Germany
    • Recruiting
    • Wilhelmsburger Krankenhaus Groß-Sand
    • Contact: Neurosurgery Department; Phone Number: +49 40 75 205; Email: sprechstunde@gross-sand.de
  • Mechernich, Germany
    • Recruiting
    • Krankenhaus Mechernich
    • Contact: Orthopaedic Department; Phone Number: +49 2443 170; Email: ortho-ambulanz@kkhm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: VCFix Spinal System

Device: VCFix Spinal System in stand-alone configuration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	6 months
Maintenance or improvement of function as measured by the 100-point Oswestry Disability Index (ODI) at 6 months compared to baseline	6 months
Absence of serious adverse device effects (SADEs): No SADEs with causality rated as definite, monitored through 1 month post-procedure (safety)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertebral height restoration (anterior, midline, and posterior aspects) at PO (Post-Operative), 1Months FU, 6 Months FU and 12Months FU.		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	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	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.		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)	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	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

• Sponsor: Amber Implants B.V.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 19, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: trauma; osteoporosis; fracture; VCF; vertebral stabilization; expandable implant; EXPAND
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Osteoporosis
• Other Study ID Numbers: CIP-VS02-EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No