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NCT05640908 · ClinicalTrials.gov registry record
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
A clinical trial of Spinal Fusion and Deformity of Spine, sponsored by SI-BONE.
- Active
- Registry status
- 200
- Enrollment target
- 9
- Study locations
NCT05640908: Active study of Spinal Fusion and Deformity of Spine, sponsored by SI-BONE.
NCT05640908 is a study of Spinal Fusion and Deformity of Spine that is active but no longer recruiting, run by SI-BONE. The registered enrollment target is 200 participants, below the 473-participant average among 19 other Spinal Fusion trials with a reported enrollment target (58% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05640908, a study of Spinal Fusion and Deformity of Spine, is active but no longer recruiting, sponsored by SI-BONE.
- ACTIVE NOT RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 9
- Study locations
Study Summary
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
Conditions Studied
Interventions
- DEVICE iFuse Bedrock Granite Implant System
Study Locations (9)
New York
- University at Buffalo - Buffalo
- Northwell Health - New York
Texas
- University of Texas Health, Houston - Houston
- Texas Back Institute - Plano
Alabama
- USA Neurosurgery - Mobile
Colorado
- University of Colorado School of Medicine - Aurora
Michigan
- Corewell Health - Royal Oak
Minnesota
- University of Minnesota - Minneapolis
North Carolina
- Pinehurst Surgical Clinic - Pinehurst
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2027-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05640908
The ClinicalTrials.gov registry entry for NCT05640908 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 19 other Spinal Fusion trials with a reported enrollment target (58% lower). The listed sponsor is SI-BONE, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Spinal Fusion appearing as the primary indexed condition, and to 1 intervention - of which iFuse Bedrock Granite Implant System is the first listed.
NCT05640908 reports 9 study locations spanning 7 distinct geographic areas - top geographies include New York, Texas, Alabama.
Frequently Asked Questions
What is clinical trial NCT05640908 about?
NCT05640908 is a clinical study titled "Pelvic Fixation and Fusion During Multilevel Spinal Surgery". PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
What is the current status of trial NCT05640908?
This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2023-06-05. Estimated completion is 2027-12.
What conditions does trial NCT05640908 study?
This clinical trial studies the following conditions: Spinal Fusion, Deformity of Spine.
What interventions are being tested in trial NCT05640908?
The interventions under investigation include: iFuse Bedrock Granite Implant System (DEVICE).
Who is sponsoring clinical trial NCT05640908?
This trial is sponsored by SI-BONE, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05640908 being conducted?
This trial has 9 study locations across Alabama, Colorado, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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