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

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ClinicalTrials.gov Identifier: NCT02182843
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Disc Degenerative Disorder Biological: Cellentra VCBM Not Applicable

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  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)
Study Start Date : March 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Patient Reported Outcomes [ Time Frame: 24 Months ]
    The primary measure of effectiveness will be assessed by the improvement in the Neck Disability Index (NDI) score.


Secondary Outcome Measures :
  1. Radiographic Fusion [ Time Frame: 24 Months ]
    The secondary measure of effectiveness will be determined by fusion rates.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182843


Locations
United States, Arizona
Barrow Neurological Associates
Phoenix, Arizona, United States, 85013
United States, Indiana
Fort Wayne Ortho
Fort Wayne, Indiana, United States, 46804
United States, Kentucky
Orthopaedic Institute of Western KY
Paducah, Kentucky, United States, 42001
United States, Ohio
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43203
United States, Pennsylvania
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Spine Team Texas
Southlake, Texas, United States, 75032
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Joel Batts Biomet Spine

Publications:

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02182843     History of Changes
Other Study ID Numbers: CS-092
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
Cellentra ACDF

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases