Overview

This trial is active, not recruiting.

Condition cervical disc degenerative disorder
Treatment cellentra vcbm
Phase phase 4
Sponsor Biomet, Inc.
Start date March 2014
End date December 2016
Trial size 80 participants
Trial identifier NCT02182843, CS-092

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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 Outcomes

Measure
Patient Reported Outcomes
time frame: 24 Months

Secondary Outcomes

Measure
Radiographic Fusion
time frame: 24 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..