MaxAn Post Market Surveillance Validation

Condition(s) targeted: DDD; Deformity; Tumor; Fracture

Phase: N/A

Status: Recruiting

Sponsored by: Biomet, Inc.

Official(s) and/or principal investigator(s):
Betsy Lowry, CCRP, Study Chair, Affiliation: Biomet, Inc.

Overall contact:
Betsy Lowry, CCRP, Phone: 800-526-2579, Ext: 2218, Email: betsy.lowry@biomet.com

This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years.

Official title: A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Disc Degeneration

Secondary outcome:

Change in Disc Height

Fusion Status

Detailed description: The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the MaxAn® Anterior Cervical Plate System. Dr. Park, et. al conducted a retrospective review and found a positive association between adjacent-level ossification following anterior cervical plate procedures and the plate-to-disc distance. 1 They concluded that when the anterior cervical plates were placed at least 5mm away from the adjacent disc spaces, there was a decrease in the likelihood of moderate-to-severe adjacent-level ossification. The design of the MaxAn Anterior Cervical Plate and accompanying technique allows this type of plate placement; therefore we will be looking at the radiographic outcomes of these subjects and comparing them to the retrospective chart review conducted by Dr. Park using the MaxAn Technique allows you to achieve plate placement of 5mm from the supraadjacent level which will help minimize the risk of adjacent level ossification.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject is scheduled to undergo a one to three-level primary spinal fusion surgery

between the levels of C2-T1 (Cervical 2 to Thoracic 1) using the MaxAn® Anterior Cervical Plate System.

- Subject has agreed to participate in this study, sign the informed consent and have

agreed to return for the 6, 12 and 24 month follow-up visits.

- Subjects or their representative must be willing and able to give informed consent.

Exclusion Criteria:

- Subject has spinal infection or inflammation at any level.

- Subject is morbidly obese, defined as a BMI greater than 40.

- Subject has a mental illness, alcoholism or drug abuse.

- Subject has a metal sensitivity/foreign body sensitivity.

- 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 and/or osteoporosis.

- Female subjects who are pregnant or plan to become pregnant in the next 24 months or

who are lactating.

- Subject who does not meet the specific indications for use of the MaxAn® Anterior

Cervical Plate System.

- Subjects participating in another clinical research study.

- Any previous cervical spinal surgery.

Betsy Lowry, CCRP, Phone: 800-526-2579, Ext: 2218, Email: betsy.lowry@biomet.com

Montgomery Spine Center, Montgomery, Alabama 36116, United States; Recruiting
Melanie Goodman, RN, Phone: 334-396-9252, Email: melspine@gmail.com
Timothy A Holt, MD, Principal Investigator

Community Neurosurgery, Indianapolis, Indiana 46219, United States; Recruiting
Ashley Johnson, RN, Phone: 317-355-1473, Email: tuttlear@aol.com
Robert Sloan, MD, Principal Investigator

LSU Health Sciences Center, New Orleans, Louisiana 70112, United States; Recruiting
Kalyn B Horst, Phone: 504-568-6123, Email: khorst@lsuhsc.edu
Erich Richter, MD, Principal Investigator

Maryland Spine and Brain, Annapolis, Maryland 21401, United States; Recruiting
Kathryn Watts, Phone: 410-266-2721, Email: kwatts@mdbrainandspine.org
Gary Dix, MD, Principal Investigator

Dr. John T. Houten, Bronx, New York 10467, United States; Not yet recruiting
Rani Nasser, MD, Phone: 718-920-7470, Email: rani.nasser@gmail.com
John T Houten, MD, Principal Investigator

Cary Orthopedics, Cary, North Carolina 27518, United States; Recruiting
Sameer Mathur, MD, Phone: 919-297-0000, Email: smathur@caryortho.com
Sameer Mathur, MD, Principal Investigator

DFW Center for Spinal Disorders, Fort Worth, Texas 76107, United States; Completed

Starting date: June 2011
Last updated: September 19, 2012