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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.

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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.

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

FieldValue
Enrollment Target 200 participants
Start Date 2023-06-05
Est. Completion 2027-12
SI-BONE

10 total trials

What the registry record for NCT05640908 still lists

NCT05640908 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 473-participant average among 19 other Spinal Fusion trials with a reported enrollment target (58% lower).

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 lists 9 locations in 7 states (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.

Similar trials for Spinal Fusion

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05640908's enrollment target sits among peer trials

200 7th of 19 higher than 13 of 19 other Spinal Fusion trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Spinal Fusion trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05640908, the US trial registry maintained by the National Library of Medicine. NCT05640908 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.