TERMINATED

Comparative Analysis of Virtuos and Autograft in Lumbar Fusion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Post-Market, Multicenter Comparative Analysis of the Efficacy of Virtuos and Autograft Bone Graft in Lumbar Fusion Surgery

Quick Facts

Study Start:2022-11-14
Study Completion:2024-05-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05614284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. *
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Central CT Neurosurgery & Spine
New Britain, Connecticut, 06051
United States
Michigan Brain and Spine
Royal Oak, Michigan, 48073
United States
University of Texas South Western
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Orthofix Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-14
Study Completion Date2024-05-16

Study Record Updates

Study Start Date2022-11-14
Study Completion Date2024-05-16

Terms related to this study

Keywords Provided by Researchers

  • Lumbar Fusion
  • Cellular Based Lyograft
  • TLIF

Additional Relevant MeSH Terms

  • Degenerative Disc Disease