NCT05614284

Brief Summary

Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 14, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

November 4, 2022

Last Update Submit

November 21, 2025

Conditions

Degenerative Disc Disease

Keywords

Lumbar FusionCellular Based LyograftTLIF

Outcome Measures

Primary Outcomes (1)

  • Successful Fusion

    Fusion status at Twelve months postoperative

    Twelve months

Secondary Outcomes (2)

  • Clinical Outcomes

    Twelve months

  • Safety Profile

    Twelve and Twenty-four months

Study Arms (2)

Virtuos

EXPERIMENTAL

Virtuos +/- Local Bone

Device: Virtuos

Autograft

ACTIVE COMPARATOR

Autograft +/- Allograft Chips

Device: Virtuos

Interventions

VirtuosDEVICE

Use of autograft or Virtuos Lyograft as an adjunct to spinal fusion in TLIF.

Also known as: Autograft
AutograftVirtuos

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age at the time of surgery
  • Undergoing lumbar spine fusion surgery with one of the following bone grafting options:
  • Virtuos
  • Virtuos 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:
  • +10 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Central CT Neurosurgery & Spine

New Britain, Connecticut, 06051, United States

Location

Michigan Brain and Spine

Royal Oak, Michigan, 48073, United States

Location

University of Texas South Western

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2:1 Enrollment: Virtuos vs. Autograft
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 14, 2022

Study Start

November 14, 2022

Primary Completion

May 16, 2024

Study Completion

May 16, 2024

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)