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

NCT07301749 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-12-24

No results posted yet for this study

Summary

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

  • Vertebral Compression Fracture

Interventions

DEVICE

VCFix Spinal System in stand-alone configuration

The distinguishing features of this inetrvention reside in: 1. 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. 2. 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. 3. 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. 4. 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.

Sponsors & Collaborators

  • Amber Implants B.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2027-07-31
Completion
2028-12-31

Countries

  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301749 on ClinicalTrials.gov