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

Cervical Disc Degenerative Disorder Clinical Trial

— VCBM/ACDF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182843
• Other study ID #: CS-092
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: January 2018

Study information

• Verified date: February 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cervical Disc Degenerative Disorder
• Intervertebral Disc Degeneration

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Fort Wayne Ortho	Fort Wayne	Indiana
United States	Orthopaedic Institute of Western KY	Paducah	Kentucky
United States	The Rothman Institute	Philadelphia	Pennsylvania
United States	Barrow Neurological Associates	Phoenix	Arizona
United States	Spine Team Texas	Southlake	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

References & Publications (14)

Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8. — View Citation

Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010 Jun;10(6):469-74. doi: 10.1016/j.spinee.2010.02.007. Epub 2010 Apr 1. — View Citation

Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, Lauryssen C, Ohnmeiss DD, Boltes MO. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine. 2011 Oct;15(4):348-58. doi: 10.3171/2011.5.SPINE10769. Epub 2011 Jun 24. Erratum in: J Neurosurg Spine. 2012 Mar;16(3):322. — View Citation

Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6. — View Citation

Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. Review. — View Citation

Gore DR, Sepic SB. Anterior cervical fusion for degenerated or protruded discs. A review of one hundred forty-six patients. Spine (Phila Pa 1976). 1984 Oct;9(7):667-71. — View Citation

Löfgren H, Engquist M, Hoffmann P, Sigstedt B, Vavruch L. Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up. Eur Spine J. 2010 Mar;19(3):464-73. doi: 10.1007/s00586-009-1161-z. Epub 2009 Sep 18. — View Citation

McConnell JR, Freeman BJ, Debnath UK, Grevitt MP, Prince HG, Webb JK. A prospective randomized comparison of coralline hydroxyapatite with autograft in cervical interbody fusion. Spine (Phila Pa 1976). 2003 Feb 15;28(4):317-23. — View Citation

Miller LE, Block JE. Safety and effectiveness of bone allografts in anterior cervical discectomy and fusion surgery. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2045-50. doi: 10.1097/BRS.0b013e3181ff37eb. Review. — View Citation

Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zdeblick TA. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. 2007 Mar;6(3):198-209. — View Citation

Palit M, Schofferman J, Goldthwaite N, Reynolds J, Kerner M, Keaney D, Lawrence-Miyasaki L. Anterior discectomy and fusion for the management of neck pain. Spine (Phila Pa 1976). 1999 Nov 1;24(21):2224-8. — View Citation

Samartzis D, Shen FH, Goldberg EJ, An HS. Is autograft the gold standard in achieving radiographic fusion in one-level anterior cervical discectomy and fusion with rigid anterior plate fixation? Spine (Phila Pa 1976). 2005 Aug 1;30(15):1756-61. — View Citation

Söderlund CH, Pointillart V, Pedram M, Andrault G, Vital JM. Radiolucent cage for cervical vertebral reconstruction: a prospective study of 17 cases with 2-year minimum follow-up. Eur Spine J. 2004 Dec;13(8):685-90. Epub 2004 Jun 26. — View Citation

Young BA, Walker MJ, Strunce JB, Boyles RE, Whitman JM, Childs JD. Responsiveness of the Neck Disability Index in patients with mechanical neck disorders. Spine J. 2009 Oct;9(10):802-8. doi: 10.1016/j.spinee.2009.06.002. Epub 2009 Jul 25. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	12 months after device implantation
Secondary	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	24 Months