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NCT01430299 · ClinicalTrials.gov registry record · NA

Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion

A NA study of Spondylosis and Stenosis, sponsored by SeaSpine.

Completed
Registry status
NA
Development phase
43
Enrollment target
1
Study location

NCT01430299 is a NA study of Spondylosis and Stenosis that has completed, run by SeaSpine. The registered enrollment target is 43 participants, below the 67-participant average among 8 other Spondylosis trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01430299, a NA study of Spondylosis and Stenosis, has completed, sponsored by SeaSpine.

COMPLETED
Registry status
NA
Development phase
43 participants
Enrollment target
1
Study location

Study Summary

The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort.

Interventions

  • DEVICE Demineralized Bone Matrix
  • DEVICE rh-BMP2

Study Locations (1)

California

  • University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery - Sacramento

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2011-06
Est. Completion 2016-10
Phase NA

Sponsor

SeaSpine

4 total trials

What the Registry Record Tells You About NCT01430299

The ClinicalTrials.gov registry entry for NCT01430299 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 67-participant average among 8 other Spondylosis trials with a reported enrollment target (36% lower). The listed sponsor is SeaSpine, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Spondylosis appearing as the primary indexed condition, and to 2 interventions - of which Demineralized Bone Matrix is the first listed.

NCT01430299 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01430299 about?

NCT01430299 is a clinical study titled "Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion". The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort.

What is the current status of trial NCT01430299?

This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2011-06. Estimated completion is 2016-10.

What conditions does trial NCT01430299 study?

This clinical trial studies the following conditions: Spondylosis, Stenosis, Degenerative Changes.

What interventions are being tested in trial NCT01430299?

The interventions under investigation include: Demineralized Bone Matrix (DEVICE), rh-BMP2 (DEVICE).

Who is sponsoring clinical trial NCT01430299?

This trial is sponsored by SeaSpine, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01430299 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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