A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Public ClinicalTrials.gov record NCT07920484. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Prospective, Multicenter, Post-Market Clinical Study Collecting Real-World Data of the VCFix Spinal System in Stand-Alone Configuration for Vertebral Augmentation (EXPAND-US)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed as a prospective, post-market, multi-center, single-arm study to collect real-world data of the VCFix Spinal System used in US clinical practice. Approximately 5 centers in the US will enroll subjects with VCF in a non-randomized fashion, and VCFix will be used within its cleared purpose and indications for use. The study has been designed to be methodologically compatible with the EU EXPAND (CIP-VS02-EU) study, thereby aiming for the pooling of data to the EU study. Data pooling will be pursued only as a sensitivity analysis if pre-specified similarity criteria are met. The US study provides meaningful real-world evidence regardless of pooling feasibility. The targeted patient population, assessment schedule, and study endpoints are therefore similar to those of the EU EXPAND study.
Study identification
- NCT ID
- NCT07920484
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2026 (Actual)
- Primary completion
- Jul 21, 2027 (Estimated)
- Completion
- Dec 31, 2028 (Estimated)
- Last update posted
- Nov 5, 2026
2026 – 2028
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Montefiore Medical Center | New York | New York | 10467 | Recruiting |
| University of Oklahoma Health Campus | Oklahoma City | Oklahoma | 73104 | Not yet recruiting |
| Rothman Orthopaedics | Philadelphia | Pennsylvania | 19107 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07920484, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 5, 2026 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07920484 live on ClinicalTrials.gov.