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Comparative Analysis of Virtuous and Autograft in Lumbar Fusion

Primary Purpose

Degenerative Disc Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtuos
Sponsored by
Orthofix Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Lumbar Fusion, Cellular Based Lyograft, TLIF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Inclusion criteria: At least 18 years of age at the time of surgery Undergoing lumbar spine fusion surgery with one of the following bone grafting options: Virtuous Virtuous with Autograft (local bone) Autograft Autograft + allograft (cancellous bone chips) Subject must have a documented diagnosis of DDD. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings: Instability as defined by >3mm translation or >5 degrees angulation Osteophyte formation of facet joints or vertebral endplates Decreased disc height, on average by >2mm, but dependent upon the spinal level Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule Herniated nucleus pulposus Facet joint degeneration/changes; and/or Vacuum phenomenon Subject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena: Radiculopathy Sensory deficit Motor weakness Reflex changes Subject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1). The number of levels decompressed must equal the number of levels fused. Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study Subject must be willing and able to sign an informed consent document. Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen. Exclusion Criteria: Exclusion criteria: Subject is under 18 years of age (<18) at the time of consent Subject has had prior lumbar spine fusion surgery at any level Subject has greater than grade 1 spondylolisthesis of the lumbar spine Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted) Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesis Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection

Sites / Locations

  • Michigan Brain and SpineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtuous

Autograft

Arm Description

Virtuous +/- Local Bone

Autograft +/- Allograft Chips

Outcomes

Primary Outcome Measures

Successful Fusion
Fusion status at Twelve months postoperative

Secondary Outcome Measures

Clinical Outcomes
Patient Reported Outcomes (PROM): Disability and Pain
Safety Profile
Incidence of Adverse Events and Serious Adverse Events through Twelve and Twenty-four months.

Full Information

First Posted
November 4, 2022
Last Updated
November 10, 2022
Sponsor
Orthofix Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05614284
Brief Title
Comparative Analysis of Virtuous and Autograft in Lumbar Fusion
Official Title
A Prospective, Post-Market, Multicenter Comparative Analysis of the Efficacy of Virtuous and Autograft Bone Graft in Lumbar Fusion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Anticipated)
Primary Completion Date
March 2, 2025 (Anticipated)
Study Completion Date
December 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthofix Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuous or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental posterolateral fusion as directed by physician, but must comply with FDA approved/cleared indication for use and labeling.
Detailed Description
The purpose of this study is to compare clinical and radiographic outcomes in patients undergoing transforaminal lumbar interbody fusion (minimally invasive or open) with either Virtuous bone graft or autograft/allograft bone graft. Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuous or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental posterolateral fusion as directed by physician, but must comply with FDA approved/cleared indication for use and labeling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
Lumbar Fusion, Cellular Based Lyograft, TLIF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2:1 Enrollment: Virtuous vs. Autograft
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtuous
Arm Type
Experimental
Arm Description
Virtuous +/- Local Bone
Arm Title
Autograft
Arm Type
Active Comparator
Arm Description
Autograft +/- Allograft Chips
Intervention Type
Device
Intervention Name(s)
Virtuos
Other Intervention Name(s)
Autograft
Intervention Description
Use of autograft or Virtuous Lyograft as an adjunct to spinal fusion in TLIF.
Primary Outcome Measure Information:
Title
Successful Fusion
Description
Fusion status at Twelve months postoperative
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Clinical Outcomes
Description
Patient Reported Outcomes (PROM): Disability and Pain
Time Frame
Twelve months
Title
Safety Profile
Description
Incidence of Adverse Events and Serious Adverse Events through Twelve and Twenty-four months.
Time Frame
Twelve and Twenty-four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria: At least 18 years of age at the time of surgery Undergoing lumbar spine fusion surgery with one of the following bone grafting options: Virtuous Virtuous with Autograft (local bone) Autograft Autograft + allograft (cancellous bone chips) Subject must have a documented diagnosis of DDD. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings: Instability as defined by >3mm translation or >5 degrees angulation Osteophyte formation of facet joints or vertebral endplates Decreased disc height, on average by >2mm, but dependent upon the spinal level Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule Herniated nucleus pulposus Facet joint degeneration/changes; and/or Vacuum phenomenon Subject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena: Radiculopathy Sensory deficit Motor weakness Reflex changes Subject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1). The number of levels decompressed must equal the number of levels fused. Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study Subject must be willing and able to sign an informed consent document. Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen. Exclusion Criteria: Exclusion criteria: Subject is under 18 years of age (<18) at the time of consent Subject has had prior lumbar spine fusion surgery at any level Subject has greater than grade 1 spondylolisthesis of the lumbar spine Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted) Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesis Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Gunter, MPH
Phone
9015962386
Email
chrisgunter@orthofix.com
Facility Information:
Facility Name
Michigan Brain and Spine
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramiro De La Torre, MD
Phone
248-898-5000
Email
ramiroperez@icloud.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Analysis of Virtuous and Autograft in Lumbar Fusion

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