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.
NCT07920484, Recruiting, Amber Implants B.V.
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | 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. | ClinicalTrials.gov |
| NCT number | NCT07920484 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Amber Implants B.V. | ClinicalTrials.gov |
| Conditions | Vertebra Compression Fracture | ClinicalTrials.gov |
| Interventions | VCFix Spinal System in stand-alone configuration | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of serious adverse events (SAEs) related to the device and/or investigational procedure (safety) | 1 month | Incidence of serious adverse events (SAEs) related to the device and/or investigational procedure within 30 days post-procedure. This includes SAEs resulting from mechanical malfunction, structural compromise, device failure, or loss of intended function, as well as events representing deviations from the device's intended medical purpose. | ClinicalTrials.gov |
| Primary | Vertebral fracture-related pain as assessed by the Numeric Pain Rating Scale (NPRS) | 6 months | Difference in vertebral fracture-related pain from baseline 6 months post procedure measured by the 11-point (0 = no pain, 10 is worst pain) Numerical Pain Rating Scale (NPRS). | ClinicalTrials.gov |
| Primary | Functional disability, measured by the Oswestry disability index (ODI) | 6 months | Difference in functional disability, measured by the Oswestry disability index (ODI) (0-100 scale, where 0 is no disability and 100 is bed bound), from baseline to 6 months post procedure. | ClinicalTrials.gov |
| Secondary | Vertebral height difference (anterior, midline, and posterior aspects) | Post-Operative, 1Month FU, 6 Months FU, 12 Months FU | Vertebral height difference (anterior, midline, and posterior aspects) at PO (Post-OP), 1M FU, 6M FU and 12M FU as compared to baseline. | ClinicalTrials.gov |
| Secondary | Kyphotic angle and Cobb angle improvement at Post-Operative, 1 Month FU, 6 Months FU and 12 Months FU. | Post-Operative, 1 Month FU, 6 Months FU and 12 Months FU. | Kyphotic angle and Cobb angle improvement | ClinicalTrials.gov |
| Secondary | Vertebral fracture-related pain as assessed by the Numeric Pain Rating Scale (NPRS) | Discharge, 1, 3, 6 and 12 Months FU compared to baseline. | Difference in vertebral fracture-related pain from baseline to Discharge, 1, 3, 6 and 12 Months post procedure measured by the 11-point (0 = no pain, 10 is worst pain) Numerical Pain Rating Scale (NPRS). | ClinicalTrials.gov |
| Secondary | Functional disability, measured by the Oswestry disability index (ODI) | Discharge, 1, 3, 6 and 12 months FU | Improvement in function (measured by the 100-point Oswestry Disability Index (ODI)) at discharge, 1, 3, 6 and 12 months FU compared to baseline. | ClinicalTrials.gov |
| Secondary | 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 | Improvement of Health-related quality of life (HRQoL) | ClinicalTrials.gov |
| Secondary | Device-related serious adverse events assessed at 12- and 24- months post-procedure. | 12 months FU, 24 months FU | Device-related serious adverse events | ClinicalTrials.gov |
| Secondary | All (per protocol reportable) adverse events assessed at 12- and 24- months post-procedure. | 12 Months FU, 24 Months FU | All (per protocol reportable) adverse events assessed at 12- and 24- months post-procedure. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)