Clinical trial NCT02182843: Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)
Official title: Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Disc Degenerative Disorder
Keywords: Cellentra ACDF
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Change in NDI From Baseline
timeFrame: 12 months after device implantation
Secondary outcomes:
measure: Number of Participants With Radiographic Success at 24 Months
timeFrame: 24 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Associates
state: Arizona
city: Fort Wayne
country: United States
facility: Fort Wayne Ortho
state: Indiana
city: Paducah
country: United States
facility: Orthopaedic Institute of Western KY
state: Kentucky
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Southlake
country: United States
facility: Spine Team Texas
state: Texas
Study officials:
affiliation: Biomet Spine
name: Joel Batts
role: STUDY_DIRECTOR
References:
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