Actively Recruiting
A Prospective Multicenter Clinical Investigation Evaluating the Safety and Efficacy of the VCFix Spinal System in Stand-alone Configuration for Vertebral Augmentation (EXPAND)
Led by Amber Implants B.V. · Updated on 2025-12-24
103
Participants Needed
3
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the VCFix Spinal System as a treatment for Vertebral Compression Fractures. The study focuses on reducing pain related to vertebral fractures and improving physical function and mobility. It also ensures the absence of serious adverse events caused by the device or procedure. This clinical investigation is prospective and conducted at multiple centers, sponsored by Amber Implants B.V. The treatment involves the use of the VCFix Spinal System in a stand-alone configuration. This device allows in situ adjustment to restore vertebral height and correct spinal alignment. It features a titanium structure designed to promote natural bone healing without the use of bone cement, potentially reducing side effects. The system also stabilizes the vertebra by connecting different parts of the spine using a pedicle screw component. Participants receive this device through a surgical procedure. Participants will be involved in assessments measuring pain reduction, physical function, vertebral height restoration, spinal angles, and quality of life at various time points including discharge, 1, 3, 6, 12, and 24 months after the procedure. Safety monitoring includes tracking serious adverse device effects up to one month post-procedure and adverse events up to 24 months. The total duration of participation covers these follow-up visits to evaluate long-term outcomes and device performance.
CONDITIONS
Brief Title
A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 85 years
- Single vertebral fracture classified as Type A compression injury in the thoracic or lumbar spine
- Fracture less than 6 weeks old or showing signs of reducibility
- Vertebral height loss between 10% and 60% in the anterior or mid third of the vertebral body
- Suitable vertebral anatomy for device implantation based on MRI/CT scans
- Back pain score of 5 or higher on the Numerical Pain Rating Scale
- Candidate for surgical intervention as determined by the investigator
- Body Mass Index less than 35
- Mentally capable of complying with study requirements
- Able to understand risks and provide written informed consent
You will not qualify if you...
- Presence of neoplasms involving the spinal canal
- Non-mobile or older fractures over 6 weeks without signs of reducibility
- Spondylolisthesis greater than Grade 1 at the target vertebra
- Local kyphotic angle over 30 degrees
- Pre-existing vertebral fractures prior to the index fracture
- Need for anterior stabilization of the fracture
- Fractures involving the pedicle
- Spinal cord compression or canal compromise requiring decompression
- Severe back pain due to causes other than acute fracture with pain score over 5
- Diagnosed herniated nucleus pulposus or severe spinal stenosis causing pain
- Pain requiring daily narcotic medication
- Pre-existing neurological deficits, radiculopathy, or myelopathy
- Uncontrolled diabetes with HbA1c over 8%
- Severe cardiopulmonary deficiencies or other conditions impacting study outcomes
- Contraindications to MRI and radionuclide bone scans
- Participation in other interfering clinical studies
- Life expectancy less than study duration or receiving palliative care
- Non-ambulatory status before fracture
- Allergy to device components
- Active or incompletely treated infections
- Systemic bone diseases other than osteoporosis
- Evidence of alcohol or drug abuse
- Long-term steroid therapy over 30 mg daily for more than 3 months
- Current anti-cancer or anti-HIV therapy
- Pregnancy or unwillingness to use contraception during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-operative period
Participants undergo implantation of the VCFix Spinal System to treat vertebral compression fractures.
1 implantation visit (in-person) plus post-operative care
Duration - Up to 24 months
Participants are monitored for safety and efficacy outcomes following implantation.
Visits at discharge, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure
Trial Site Locations
Total: 3 locations
1
Centre Hospitalier Métropole de Savoie
Chambéry, France
Not Yet Recruiting
2
Wilhelmsburger Krankenhaus Groß-Sand
Hamburg, Germany
Actively Recruiting
3
Krankenhaus Mechernich
Mechernich, Germany
Actively Recruiting
Research Team
C
Clinical Research Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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