Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03425682
Other study ID # CLP-0001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 14, 2018
Est. completion date June 30, 2021

Study information

Verified date July 2021
Source Aziyo Biologics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 up to 50 subjects undergoing ACDF surgery and up to 50 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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date June 30, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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). - Other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count. - Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.

Study Design


Intervention

Other:
ViBone
Viable Bone Allograft

Locations

Country Name City State
United States Anne Arundel Medical Group Annapolis Maryland
United States Orthopedic Specialists of Austin Austin Texas
United States Connecticut Neck & Back Specialists, LLC Danbury Connecticut
United States Spine Institute of San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Aziyo Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fusion Fusion rates for ViBone from surgical procedure 12 months
Secondary ODI Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion 12 months
Secondary NDI Neck Disability Index (NDI) improvement relative to baseline for cervical spine fusion 12 months
Secondary VAS Visual Analog Scale (VAS) for pain improvement relative to baseline (Pain scale from 0-10, with 0 being No Pain and 10 being Worst Pain) 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Active, not recruiting NCT05114135 - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study) N/A
Suspended NCT04735185 - Stem Cells vs. Steroids for Discogenic Back Pain N/A
Withdrawn NCT03223701 - Efficacy of Using Solum IV and BMC With GFC in TLIF Phase 4
Completed NCT04057235 - Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Not yet recruiting NCT06000319 - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Active, not recruiting NCT02969616 - Trinity Elite in Lumbar Fusion
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Completed NCT02104167 - Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Completed NCT00996073 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion Phase 2
Completed NCT00965380 - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
Completed NCT00758719 - Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Completed NCT00165893 - Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease Phase 4
Terminated NCT01494493 - Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease N/A
Recruiting NCT04727385 - Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease N/A
Completed NCT04849429 - Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain Phase 1
Recruiting NCT04469387 - Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion N/A
Recruiting NCT04056520 - Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Completed NCT04119466 - Stabilizing Training in Degenerative Disc Disease N/A