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ViBone in Cervical and Lumbar Spine Fusion | Clinical Trials | Clareo Health

COMPLETED

ViBone in Cervical and Lumbar Spine Fusion

A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion

NCT03425682•Elutia Inc.

Summary

Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

Detailed Description

This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for subjects undergoing ACDF surgery and subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, 18-80 years of age
•For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7
•For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1
•Patient signed Consent Form with HIPAA Authorization
•Appropriate candidate for surgery
•Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available).

Exclusion Criteria

•Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
•Treatment with radiotherapy
•Acute or chronic systemic or localized spinal infections
•Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine
•Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for
•TLIF, PLIF, ALIF, or LLIF patients) spine
•Nursing mothers or women who are pregnant or plan to become pregnant during the course of the study
•Current or recent history of malignancy or infectious disease. Patients with current or recent history of basal cell carcinoma are eligible.
•Inability to provide informed consent
•Rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (bone density score of ≤-2.5).
+2 more criteria

Locations (4)

Spine Institute of San Diego

San Diego, California, United States

Connecticut Neck & Back Specialists, LLC

Danbury, Connecticut, United States

Anne Arundel Medical Group

Annapolis, Maryland, United States

Orthopedic Specialists of Austin

Austin, Texas, United States

Key Dates

Start Date

May 14, 2018

Primary Completion Date

January 15, 2021

Completion Date

June 30, 2021

Last Updated

March 4, 2025

Enrollment

118

ACTUAL participants

Conditions

SpondylosisCervical SpondylosisSpondylolisthesisHerniated Nucleus PulposusDegenerative Disc Disease

Interventions

ViBone

OTHER

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

NCT05029726

Lumbar Spinal StenosisLumbar Disc Herniation+8 more

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RECRUITING

Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

NCT06601634

Neck PainCervical Spondylosis+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ViBone in Cervical and Lumbar Spine Fusion

Inclusion Criteria

Exclusion Criteria

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

Study on the Treatment of C/S of Qi Stagnation and Blood-stasis Type by Moving Cupping with Bloodletting

PREventing Pain After Surgery

Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure