Recruitment

Recruitment Status
Completed
Estimated Enrollment
215

Inclusion Criterias

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.
The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies.
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 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.
The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies.
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 was unresponsive to conservative treatment for at least 6 weeks unless clinically indicated sooner.
The subject is 18 years of age or older.

Exclusion Criterias

Subject is morbidly obese, defined as a BMI greater than 40.
Subject has inadequate tissue coverage over the operative site.
Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
...
Subject is morbidly obese, defined as a BMI greater than 40.
Subject has inadequate tissue coverage over the operative site.
Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
Subject has a metal sensitivity/foreign body sensitivity.
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.
Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
Subject has an active local or systemic infection.
Subject has sensitivity or allergies to any of the processing agents. (See package insert for Cellentra™ VCBM).
Subject is a prisoner.
Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis.
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.
Any previous cervical spinal surgery.
Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
Subject is currently involved in another investigational drug or device study that could confound study data.
Subject who does not meet the specific indications for use of the Cellentra™ VCBM or MaxAn® Anterior Cervical Plate System.

Summary

Conditions
Cervical Disc Degenerative Disorder
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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. Subj...

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.

Inclusion Criterias

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.
The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies.
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 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.
The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies.
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 was unresponsive to conservative treatment for at least 6 weeks unless clinically indicated sooner.
The subject is 18 years of age or older.

Exclusion Criterias

Subject is morbidly obese, defined as a BMI greater than 40.
Subject has inadequate tissue coverage over the operative site.
Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
...
Subject is morbidly obese, defined as a BMI greater than 40.
Subject has inadequate tissue coverage over the operative site.
Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
Subject has a metal sensitivity/foreign body sensitivity.
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.
Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
Subject has an active local or systemic infection.
Subject has sensitivity or allergies to any of the processing agents. (See package insert for Cellentra™ VCBM).
Subject is a prisoner.
Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis.
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.
Any previous cervical spinal surgery.
Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
Subject is currently involved in another investigational drug or device study that could confound study data.
Subject who does not meet the specific indications for use of the Cellentra™ VCBM or MaxAn® Anterior Cervical Plate System.

Locations

Southlake, Texas, 75032
Paducah, Kentucky, 42001
Columbus, Ohio, 43203
Phoenix, Arizona, 85013
Philadelphia, Pennsylvania, 19107
...
Southlake, Texas, 75032
Paducah, Kentucky, 42001
Columbus, Ohio, 43203
Phoenix, Arizona, 85013
Philadelphia, Pennsylvania, 19107
Fort Wayne, Indiana, 46804

Tracking Information

NCT #
NCT02182843
Collaborators
Not Provided
Investigators
Study Director: Joel Batts Biomet Spine