MaxAn Post Market Surveillance Validation

This study is currently recruiting participants.
Verified September 2013 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01343693
First received: April 27, 2011
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition
DDD
Deformity
Tumor
Fracture

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Disc Degeneration [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

    Disc Degeneration, including Adjacent Level Degeneration, will be qualitatively graded in accordance with the following definitions 0. None: No disc space narrowing, no osteophytes, no endplate sclerosis

    1. Mild: < 33% disc space narrowing, mild osteophytes, no endplate sclerosis
    2. Moderate: 33% - 66% disc space narrowing, moderate osteophytes, mild to moderate endplate sclerosis
    3. Severe: ≥ 67% disc space narrowing, severe osteophytes or bridging, severe endplate sclerosis


Secondary Outcome Measures:
  • Change in Disc Height [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Change in disc height is defined as the change in distance between the anterior-inferior (posterior-inferior) corner of the superior vertebra, and the corresponding corner of the inferior vertebra. This change is measured perpendicular to the superior endplate of the inferior vertebra. Change in average disc height is calculated as the simple average of the change in anterior and posterior disc heights. Change in disc height is calculated by subtracting the measured disc height at one time point from a baseline disc height measurement. The results will be recorded in units of millimeters.

  • Fusion Status [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

    Fusion will be assessed by an independent radiographer when data collection is complete at each site. The radiographic report (if available) and the x-rays will be sent to an independent radiologist for review at the end of the study. X-rays will be evaluated at each visit for fusion determination. The grading system is as follows:

    • Grade 1 - No graft incorporation
    • Grade 2 - Incomplete graft incorporation
    • Grade 3 - Graft Incorporation
    • Grade 4 - Solid fusion with graft incorporation


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
DDD
Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This post market surveillance study will enroll two hundred (200) subjects across 10 clinical centers within the United States with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from the pool of subjects presenting to each investigational site for an anterior cervical fusion procedure. The 10 surgeons chosen to participate in this study will be thoroughly knowledgeable in the medical, surgical and mechanical aspects of the MaxAn® Anterior Cervical Plate System. The following inclusion and exclusion criteria must be met for a patient to be considered eligible for participation in this study.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343693

Contacts
Contact: Betsy Lowry, CCRP 800-526-2579 ext 2218 betsy.lowry@biomet.com

Locations
United States, Alabama
Montgomery Spine Center Completed
Montgomery, Alabama, United States, 36116
United States, Florida
Tallahassee Neurological Clinic Recruiting
Tallahassee, Florida, United States, 32308
Contact: Lutheria Hollis    850-201-2350    lhollis@tnc-neuro.com   
Principal Investigator: Christopher Rumana, MD         
United States, Indiana
Community Neurosurgery Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Ashley Johnson, RN    317-355-1473    tuttlear@aol.com   
Principal Investigator: Robert Sloan, MD         
United States, Maryland
Maryland Spine and Brain Recruiting
Annapolis, Maryland, United States, 21401
Contact: Kathryn Watts    410-266-2721    kwatts@mdbrainandspine.org   
Principal Investigator: Gary Dix, MD         
United States, Michigan
Henry Ford Hospital - Neurosurgery Recruiting
West Bloomfield, Michigan, United States, 48322
Contact: Kelly Tundo, CCRP    313-916-1102    Kciach1@hfhs.org   
Principal Investigator: Steven Kalkanis, MD         
United States, North Carolina
Cary Orthopedics Recruiting
Cary, North Carolina, United States, 27518
Contact: Sameer Mathur, MD    919-297-0000    smathur@caryortho.com   
Principal Investigator: Sameer Mathur, MD         
United States, Texas
DFW Center for Spinal Disorders Active, not recruiting
Fort Worth, Texas, United States, 76107
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Chair: Betsy Lowry, CCRP Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01343693     History of Changes
Other Study ID Numbers: CS-059
Study First Received: April 27, 2011
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
DDD
Deformity
Tumor
Fracture
Cervical

Additional relevant MeSH terms:
Congenital Abnormalities
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 23, 2014