Comparative Analysis of Virtuos and Autograft in Lumbar Fusion

NCT ID: NCT05614284

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2024-05-16

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.

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 Virtuos bone graft or autograft/allograft bone graft.

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.

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtuos

Virtuos +/- Local Bone

Group Type: EXPERIMENTAL

Virtuos

Intervention Type: DEVICE

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

Autograft

Autograft +/- Allograft Chips

Group Type: ACTIVE_COMPARATOR

Virtuos

Intervention Type: DEVICE

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

Interventions

Virtuos

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

Intervention Type: DEVICE

Other Intervention Names

Autograft

Eligibility Criteria

Inclusion Criteria

1. At least 18 years of age at the time of surgery

2. Undergoing lumbar spine fusion surgery with one of the following bone grafting options:

1. Virtuos

2. Virtuos with Autograft (local bone)

3. Autograft

4. Autograft + allograft (cancellous bone chips)

3. 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:

1. Instability as defined by >3mm translation or >5 degrees angulation

2. Osteophyte formation of facet joints or vertebral endplates

3. Decreased disc height, on average by >2mm, but dependent upon the spinal level

4. Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule

5. Herniated nucleus pulposus

6. Facet joint degeneration/changes; and/or

7. Vacuum phenomenon

4. Subject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena:

1. Radiculopathy

2. Sensory deficit

3. Motor weakness

4. Reflex changes

5. Subject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1).

6. The number of levels decompressed must equal the number of levels fused.

7. Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery.

8. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study

9. Subject must be willing and able to sign an informed consent document.

10. 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

1. Subject is under 18 years of age (<18) at the time of consent

2. Subject has had prior lumbar spine fusion surgery at any level

3. Subject has greater than grade 1 spondylolisthesis of the lumbar spine

4. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted)

5. Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesis

6. Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthofix Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas South Western

Dallas, Texas, United States

Central CT Neurosurgery & Spine

New Britain, Connecticut, United States

Michigan Brain and Spine

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

CP - 2201VLF

Identifier Type: -

Identifier Source: org_study_id