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

Primary Purpose

Cervical Disc Degenerative Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cellentra VCBM

About this trial

This is an interventional treatment trial for Cervical Disc Degenerative Disorder focused on measuring Cellentra ACDF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Barrow Neurological Associates
Fort Wayne Ortho
Orthopaedic Institute of Western KY
Ohio State University Wexner Medical Center
The Rothman Institute
Spine Team Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cellentra VCBM

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in NDI From Baseline

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%.

Secondary Outcome Measures

Number of Participants With Radiographic Success at 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

Full Information

NCT ID

NCT02182843

First Posted

July 2, 2014

Last Updated

March 14, 2019

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT02182843

Brief Title

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

Acronym

VCBM/ACDF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Disc Degenerative Disorder

Keywords

Cellentra ACDF

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cellentra VCBM

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Cellentra VCBM

Intervention Description

Primary Outcome Measure Information:

Title

Change in NDI From Baseline

Description

Time Frame

12 months after device implantation

Secondary Outcome Measure Information:

Title

Number of Participants With Radiographic Success at 24 Months

Description

Time Frame

24 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Batts

Organizational Affiliation

Biomet Spine

Official's Role

Study Director

Facility Information:

Facility Name

Barrow Neurological Associates

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Fort Wayne Ortho

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

Orthopaedic Institute of Western KY

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42001

Country

United States

Facility Name

Ohio State University Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43203

Country

United States

Facility Name

The Rothman Institute

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Spine Team Texas

City

Southlake

State/Province

Texas

ZIP/Postal Code

75032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

6505833

Citation

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Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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

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