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

NCT07301749 | Recruiting DMC

• 1 other identifier: CIP-VS02-EU
• Study Type: interventional
• Target: 148
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Vertebral Compression Fracture

Keywords

VCF; EXPAND; vertebral stabilization; fracture; trauma; osteoporosis; expandable implant

Outcome Measures

Primary Outcomes (3)

• Reduction of more than 2 points in vertebral fracture-related pain intensity at 6 months after the index procedure compared to baseline as measured by a 11-point Numerical Pain Rating Scale (NPRS)

  6 months

• Maintenance or improvement of function as measured by the 100-point Oswestry Disability Index (ODI) at 6 months compared to baseline

  6 months

• Absence of serious adverse device effects (SADEs): No SADEs with causality rated as definite, monitored through 1 month post-procedure (safety)

  1 month

Secondary Outcomes (7)

• Vertebral height restoration (anterior, midline, and posterior aspects) at PO (Post-Operative), 1Months FU, 6 Months FU and 12Months FU.

  Post-Operative, 1Month FU, 6 Months FU, 12 Months FU

• Kyphotic angle and Cobb angle improvement at Post-Operative, 1 Month FU, 6 Months FU and 12 Months FU.

  Post-Operative, ost-Operative, 1 Month FU, 6 Months FU and 12 Months FU.

• Reduction in vertebral fracture-related pain (measured by the 11-point Numerical Pain Rating Scale (NPRS))

  Discharge, 1, 3, 6 and 12 Months FU compared to baseline.

• Improvement in function (measured by the 100-point Oswestry Disability Index (ODI)) at discharge, 1, 3, 6 and 12 months FU compared to baseline.

  Discharge, 1, 3, 6 and 12 months FU

• Improvement of Health-related quality of life (HRQoL) measured by EuroQol 5-Dimension Scale (EQ-5D-5L) at 1 Month, 3 Months, 6 Months and 12 Months post-procedure compared to baseline

  1 Month, 3 Months, 6 Months and 12 Months post-procedure compared to baseline

Study Arms (2)

Cemented cohort

EXPERIMENTAL

Implant of the VCFix device with the use of PMMA bone cement

Device: VCFix Spinal System in stand-alone configuration

Uncemented cohort

EXPERIMENTAL

Implant of the VCFix device without the use of PMMA bone cement

Device: VCFix Spinal System in stand-alone configuration

Interventions

VCFix Spinal System in stand-alone configuration DEVICE

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.

Cemented cohort; Uncemented cohort

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 21 to ≤ 85 years old.
• Single vertebral fracture which meets all of the following criteria:
• Type A fractures from AO spine classification (compression injuries);
• Vertebral fracture located in the thoracic and lumbar regions of the spine
• Fracture age \< 6 weeks or fractures with anatomic signs of reducibility (based on radiographic evidence as well as patient history)
• Vertebral fracture shows an estimated height loss in the anterior or mid third of the vertebral body (VB) of at least 10% but not more than 60% based on radiographic evidence
• Target VB has appropriate anatomy, i.e. suitable pedicle diameter, pedicle length and chord length that would allow for selection of correct implant size, as described in the IFU and based on axial MRI/CT scan before surgery
• Subject has a NPRS back pain score of ≥5
• Subject is a candidate for surgical intervention based on investigator opinion
• Subject has a body Mass Index (BMI) \< 35
• Subject is mentally capable of complying with trial protocol requirements for the duration of the study
• Subject can understand the risks and benefits of participating in the study and is able to provide written informed consent

You may not qualify if:

• Neoplasms with posterior involvement and/or presence of a mass within the spinal canal
• Non-mobile fractures (i.e., fracture is not recent (\>6 weeks), bone marrow edema or fluid or empty cleft are not visible in radiographic imaging, or fracture mode does not allow for fracture reduction in craniocaudal direction).
• Spondylolisthesis \> Grade 1 at target vertebral body(s)
• Local kyphotic angle \> 30°
• Pre-existing vertebral fracture prior to the index fracture
• Subjects that require anterior stabilization of the index fracture
• Fracture to the pedicle based on radiographic evaluation
• Spinal cord compression or canal compromise requiring decompression
• Severe back pain due to causes other than acute fracture with NPRS score\>5
• The subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
• Pain due to any other condition that requires daily narcotic (opiates or opioids) medication
• Pre-existing neurological deficit, radiculopathy or myelopathy
• Pre-existing condition or significant co-morbidity:
• Uncontrolled diabetes (HbA1c \>8%)
• Severe cardiopulmonary deficiencies

Sponsors & Collaborators

• Amber Implants B.V.: lead

Study Sites (3)

Centre Hospitalier Métropole de Savoie

Chambéry, France

NOT YET RECRUITING

Wilhelmsburger Krankenhaus Groß-Sand

Hamburg, Germany

RECRUITING

Krankenhaus Mechernich

Mechernich, Germany

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Wounds and Injuries; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Clinical Research Manager

CONTACT

+31 15 200 2151; expand@amberimplants.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study comprises two predefined cohorts, assigned based on protocol-specific criteria applied prior to treatment: * a cementless cohort, where the device is implanted without polymethylmethacrylate (PMMA) bone cement * a cemented cohort, where the device is used in conjunction with PMMA bone cement Outcomes for each cohort will be evaluated independently against an external control. No direct comparison between the study cohorts is planned.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: December 24, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); FR (1)