Last reviewed · How we verify
NCT04062630: SILVIA
SI Joint Stabilization in Long Fusion to the Pelvis
NA trial testing iFuse 3-D in Bedrock Configuration in Sacroiliac Joint Disruption in 213 participants. Completed in 15 January 2025.
17 December 2024
Quick facts
| Lead sponsor | SI-BONE, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 213 |
| Start date | 20 May 2020 |
| Primary completion | 17 December 2024 |
| Estimated completion | 15 January 2025 |
| Sites | 31 locations across Italy, United Kingdom, Germany, Australia, United States |
Drugs / interventions tested
- iFuse 3-D in Bedrock Configuration
- Multilevel Lumbar Fusion surgery
Conditions studied
- Sacroiliac Joint Disruption — all drugs for Sacroiliac Joint Disruption →
- Scoliosis Lumbar Region — all drugs for Scoliosis Lumbar Region →
Sponsor
SI-BONE, Inc. — full company profile →
Who can join
Adults 21 to 75, any sex, with Sacroiliac Joint Disruption or Scoliosis Lumbar Region. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cost-Utility Analysis of Sacroiliac Joint Fusion in High-Risk Patients Undergoing Multi-Level Lumbar Fusion to the Sacrum.
Ackerman SJ, Deol GS, Polly DW. · · 2022 · cited 8× · PMID 35966399 · DOI 10.2147/ceor.s377132 -
Is the Implant in Bone? The Accuracy of CT and Fluoroscopic Imaging for Detecting Malpositioned Pelvic Screw and SI Fusion Implants.
San Miguel-Ruiz JE, Polly D, Albersheim M, Sembrano J, et al · · 2021 · cited 3× · PMID 34552409 · DOI 10.1016/j.spinee.2021.05.453 -
The Bedrock technique with triangular titanium rods for spinopelvic fixation and sacroiliac joint fusion: is there a learning curve?
Hendricks CJ, Haselhuhn JJ, Soriano PBO, Longhurst JT, et al · · 2025 · PMID 40699381 · DOI 10.1007/s00590-025-04431-0
Verify or expand the search:
- PubMed search for NCT04062630
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other SI-BONE, Inc. trials
Trials by the same sponsor.
- NCT05426356 — Sacral Fracture Fusion/Fixation for Rapid Rehabilitation · NA · terminated
- NCT03122899 — Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants · NA · completed
- NCT01874236 — Validity and Reliability of Diagnostic Findings of SI Joint Blocking · Phase 4 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04062630 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SI-BONE, Inc.
- Last refreshed: 18 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04062630.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing