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

Study acronym: EXPAND
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: 103 to 148
    • Study completion date: Dec 31, 2028 to Dec 31, 2029
    • Study title revised
    • Study arms: 1 to 2
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults. Up to 8 hospitals in Europe will take part in the study. All participants will receive treatment with the VCFix device. The treatment will be provided according to the intended use of the device and may be performed either with or without the use of a special bone cement. Participants will be assigned to one of two study groups before treatment: Cementless group: the VCFix device is implanted without bone cement. Cemented group: the VCFix device is implanted together with bone cement. The study will assess how well the treatment works and how safe it is. Researchers will evaluate: Changes in back pain 6 months after treatment compared with before treatment. Changes in daily functioning and ability to perform everyday activities 6 months after treatment compared with before treatment. Whether any serious device-related complications occur during the first month after treatment. The results will help determine whether treatment with the VCFix device provides benefits for patients with vertebral compression fractures while maintaining an acceptable safety profile.
Trial Details
NCT Number NCT07301749
Lead Sponsor Amber Implants B.V.
Conditions
(from sponsor)		 Vertebral Compression Fracture
Related terms Fractures, Bone, Osteoporosis, Wounds and Injuries
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov