Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn) (VCBM/ACDF)

March 14, 2019 updated by: Zimmer Biomet
The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective single-arm multi-center study of Cellentra Viable Cell Bone Matrix (VCBM) and the MaxAn® Anterior Cervical Plate System when used in anterior cervical discectomy and fusion procedures. This study will enroll up to eighty (80) subjects across up to eight (8) clinical sites. Subjects will be recruited from a pool of patients presenting to investigators for an anterior cervical discectomy and fusion procedure.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Associates
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Ortho
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Orthopaedic Institute of Western KY
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Ohio State University Wexner Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • The Rothman Institute
    • Texas
      • Southlake, Texas, United States, 75032
        • Spine Team Texas

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject is scheduled to undergo a two or three level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using Cellentra™ VCBM, allograft spacers, and the MaxAn® Anterior Cervical Plate System.
  • The subject is 18 years of age or older.
  • The subject was unresponsive to conservative treatment for at least 6 weeks unless clinically indicated sooner.
  • The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies.
  • The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

Exclusion Criteria:

  1. Subject has an active local or systemic infection.
  2. Subject is morbidly obese, defined as a BMI greater than 40.
  3. Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
  4. Subject has inadequate tissue coverage over the operative site.
  5. Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis.
  6. Any previous cervical spinal surgery.
  7. Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.) or immunocompromised.
  8. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
  9. Subject who does not meet the specific indications for use of the Cellentra™ VCBM or MaxAn® Anterior Cervical Plate System.
  10. Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
  11. Subject is currently involved in another investigational drug or device study that could confound study data.
  12. Subject is a prisoner.
  13. Subject has a metal sensitivity/foreign body sensitivity.
  14. Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
  15. Subject has sensitivity or allergies to any of the processing agents. (See package insert for Cellentra™ VCBM).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cellentra VCBM
Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Biological: Cellentra VCBM
Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in NDI From Baseline
Time Frame: 12 months after device implantation
Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%.
12 months after device implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Radiographic Success at 24 Months
Time Frame: 24 Months

Radiographic fusion was assessed at each operated level using the Bridwell fusion grading system:

  • Grade I (definite) - Fused with remodeling and trabeculae
  • Grade II (probable) - Graft intact, not fully remodeled and incorporated through, no lucencies
  • Grade III (probably not) - Graft intact, but definite lucency at the top or bottom of the graft
  • Grade IV (no) - Definitely not fused, with resorption of bone graft or collapse.

Radiographic success was defined as grade 1 or 2 fusion at every operated level at 24 months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Joel Batts, Biomet Spine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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