MaxAn Post Market Surveillance Validation (MaxAn)

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

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.

Study Overview

• Status: Completed
• Conditions: Tumor; Fracture; DDD; Deformity

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.

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36116
      • Montgomery Spine Center
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46219
      • Community Neurosurgery
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Maryland Spine and Brain
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Cary Orthopedics
  • Texas
    • Fort Worth, Texas, United States, 76107
      • DFW Center for Spinal Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Anterior cervical discectomy and fusion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Differing Severity of Adjacent Level Ossification	Qualitatively assessed by an independent Radiologist using lateral radiographs Grade 0 - None Grade 1 - Mild (if the ossification extended across <50% of the disc space) Grade 2 - Moderate (if the ossification extended across ≥ 50% of the disc space) Grade 3 - Severe (if there is complete bridging of the adjacent disc space)	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Neck Disability Index (NDI)	The Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain', with the points summed to a total score. The test can be interpretated as a raw score, with a minimum score of 0 and a maximum score of 50. A higher score indicates more patient-rated disability. To use the NDI for patient decisions, a clinically important change was calculated as 5 points.	24 Months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Gary Dix, MD, Maryland Spine and Brain

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (Estimate): April 28, 2011

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Cervical; DDD; Fracture; Tumor; Deformity
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CS-059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No