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Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration

NCT07259811 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-02

No results posted yet for this study

Summary

This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and works well in early testings, so that a larger safety study can be done later to help get CE approval. The VCFix Spinal System will be used in its independent setup, within its planned use for treatment of vertebral compression fracture. It's designed to be a small early study to test safety and see if the treatment idea is possible, with one group and no blinding. Two hospitals in EU will enroll in total 10 participants with a single vertebral fracture that will undergo the same surgery.

The main test goals are: how successful the access creation of the vertebral body is using the VCFix Preparation kit according to the provided instructions, how successful the positioning of the VCFix implant is by using the VCFix Implantation kit according to the provided instructions, and how successful the fracture reduction by expanding the VCFix implant according to the provided instructions. The main safety goal is: number of device-/procedure-related major side effects through 30 days after the initial procedure.

Participant enrollment will last around 12 months. Each participant will be followed for 2 years after the implantations. All side effects related to the spine will be documented throughout the study.

Conditions

  • Vertebral Compression Fracture

Interventions

DEVICE

VCFix Spinal System in stand-alone configuration

The distinguishing features of this intervention 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

  • Avania B.V.

    collaborator UNKNOWN

  • Amber Implants B.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2026-05-14
Completion
2026-05-14

Countries

  • 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 NCT07259811 on ClinicalTrials.gov