Virtuos Bone Graft in Lumbar Fusion

• Conditions: Degenerative Disc Disease

• Registration Number: NCT06686017
• Lead Sponsor: Orthofix Inc.

Brief Summary

A post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels

Detailed Description

Single arm prospectively enrolled observational study of subjects who undergo lumbar spinal fusion at one or two levels with an anterior or lateral surgical approach using a cellular based allograft (Virtuos) as the bone graft There is no experimental intervention for this study. Subjects will be treated per standard of care by their attending physician/surgeon. The primary endpoint in this study is fusion success at 12 months. as determined by the attending physician/surgeon using CT as the imaging modality. The fusion rates observed at 12-months will be compared to an historical group of patients that underwent a one or two level lumbar fusion procedure with an anterior or lateral approach using a cellular based allograft (Trinity Elite).

Study Timeline

• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-13
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-04
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Subject must be 18 years of age (≥ 18 years) or older at the time of consent.

• Subject must undergo lumbar interbody fusion study at 1-2 contiguous levels.
• Virtuos must be the primary bone graft (≥ 50% of the total graft volume) and may be augmented with autograft or cortical or cancellous bone chips.
• 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 protocol.-

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fusion	12-months	Fusion of the spinal motion segments

Secondary Outcome Measures

Name	Time	Method
Disability (ODI)	12 months	The ODI will be used to assess disability if the patient reported outcomes are routinely collected at participating centers.
Pain (NPRS)	12 months	A pain rating scale (VAS or NRS) will be used to assess pain levels at baseline and follow-up visits, if pain assessment is routinely collected as standard of care at participating sites.

Trial Locations

Locations (1)

OrthoSC; 🇺🇸 Myrtle Beach, South Carolina, United States