What is the VCFix Spinal System studying for vertebral compression fractures?

The VCFix Spinal System is being studied to evaluate its safety and performance in treating vertebral compression fractures in adults. Researchers want to see how well the device reduces pain and improves daily functioning while monitoring any serious complications. The study is sponsored by Amber Implants B.V.

Who may be eligible for this vertebral compression fracture clinical trial?

Adults aged 21 to 85 with a single thoracic or lumbar vertebral compression fracture less than 6 weeks old or showing reducibility may be eligible. Participants must have moderate to severe back pain, a BMI under 35, and be suitable for surgery. Please review eligibility criteria for more details.

Is there any cost to participate in this vertebral compression fracture clinical trial?

Study-related care, including the device implant and all trial visits, is provided at no cost. However, personal costs such as travel or accommodation may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 21Years - 85Years

All Genders

ID07301749

Evaluating the Safety and Effectiveness of the VCFix Spinal System for Adult Vertebral Compression Fractures

Led by Amber Implants B.V. · Updated on 2026-06-22

148

Participants Needed

Research Sites

126 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the VCFix Spinal System, a medical device designed to treat specific spinal fractures called vertebral compression fractures VCFs in adults aged 21 to 85 years. This study involves up to 8 hospitals in Europe and aims to assess how well the device works and how safe it is for patients with these fractures. The study compares two groups one receiving the VCFix implant with bone cement and the other without cement. Participants will receive the VCFix device implant either with or without the use of PMMA bone cement, according to their assigned study group. The device features in situ adjustment to realign vertebrae, a titanium structure allowing natural bone healing, and the potential to stabilize severe fractures through a pedicle screw component. Treatment will follow intended use guidelines, and researchers will monitor outcomes including pain reduction, function improvement, and device-related complications. During the study, participants will be assessed for changes in back pain and daily functioning at 6 months compared to before treatment. Additional measures include vertebral height restoration, spinal angle improvements, and health-related quality of life at various time points up to 24 months. Safety will be monitored through serious adverse device effects during the first month and adverse events up to two years. The total participation duration extends through follow-up assessments to evaluate both effectiveness and safety.

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

Age: 21Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 21 to 85 years
Single vertebral compression fracture classified as Type A (compression injury) in the thoracic or lumbar spine
Fracture age less than 6 weeks or with signs it can be reduced
Vertebral height loss between 10% and 60% in the anterior or middle third of the vertebral body
Suitable vertebral anatomy for implant size selection based on MRI or CT scan
Back pain score of 5 or higher on an 11-point Numerical Pain Rating Scale
Candidate for surgical intervention as determined by investigator
Body mass index (BMI) less than 35
Mentally capable to comply with study requirements and provide informed consent

You will not qualify if you...

Neoplasms involving the posterior spine or mass in spinal canal
Non-mobile fractures older than 6 weeks without signs of reducibility
Spondylolisthesis greater than Grade 1 at target vertebra
Local kyphotic angle over 30 degrees
Pre-existing vertebral fractures before the current fracture
Need for anterior stabilization of the fracture
Fracture involving the pedicle
Spinal cord compression or canal compromise needing decompression
Severe back pain from other causes with pain score over 5
Herniated nucleus pulposus or severe spinal stenosis causing pain
Pain requiring daily narcotic medication
Pre-existing neurological deficits such as radiculopathy or myelopathy
Uncontrolled diabetes, severe cardiopulmonary deficiencies, 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
Systemic bone diseases other than osteoporosis
Alcohol or drug abuse
Long-term steroid therapy exceeding 30 mg/day for more than 3 months
Current anti-cancer or anti-HIV therapy
Pregnancy or unwillingness to use contraception if of childbearing potential

Research Team

Clinical Research Manager

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