Actively Recruiting
A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures.
Led by Amber Implants B.V. · Updated on 2025-12-24
103
Participants Needed
3
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Subject is between 21 and 85 years old
- Single vertebral fracture classified as Type A compression injury
- Fracture located in thoracic or lumbar spine
- Fracture age less than 6 weeks or shows signs of reducibility
- Vertebral body height loss between 10% and 60%
- Target vertebra has suitable anatomy for implant
- Back pain score of 5 or higher on Numerical Pain Rating Scale
- Candidate for surgical intervention based on investigator's opinion
- 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 spine or spinal canal
- Non-mobile or old fractures (older than 6 weeks) without signs of reducibility
- Spondylolisthesis greater than Grade 1 at target vertebra
- Local kyphotic angle greater than 30 degrees
- Previous vertebral fractures before the current fracture
- Need for anterior stabilization of the fracture
- Fracture involving the pedicle
- Spinal cord compression or canal compromise requiring decompression
- Severe back pain from causes other than acute fracture with pain score over 5
- Pain from herniated nucleus pulposus or severe spinal stenosis with progressive weakness
- Pain requiring daily use of narcotic medications
- Pre-existing neurological deficits, radiculopathy, or myelopathy
- Uncontrolled diabetes, severe cardiopulmonary diseases, or other significant co-morbidities
- Contraindications to MRI and radionuclide bone scan
- Participation in another interfering clinical study
- Life expectancy less than study duration or receiving palliative care
- Non-ambulatory before fracture
- Allergy to device components
- Active or untreated infections of the spine or systemic infections
- Underlying systemic bone diseases other than osteoporosis
- Evidence of alcohol or drug abuse
- Long-term steroid therapy exceeding specified dose and duration
- Current anti-cancer or anti-HIV therapy
- Pregnancy or unwillingness to use contraception if of child-bearing potential
AI-Screening
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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
CONTACT
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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