A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate
18 Years
N/A
Both
DDD, Deformity, Tumor, Fracture
Trial Information
A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Disc Degeneration
Outcome Description:
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 Mild: < 33% disc space narrowing, mild osteophytes, no endplate sclerosis Moderate: 33% - 66% disc space narrowing, moderate osteophytes, mild to moderate endplate sclerosis Severe: ≥ 67% disc space narrowing, severe osteophytes or bridging, severe endplate sclerosis
Outcome Time Frame:
24 Months
Safety Issue:
No
Principal Investigator
Betsy Lowry, CCRP
Investigator Role:
Study Chair
Investigator Affiliation:
Biomet, Inc.
Authority:
United States: Institutional Review Board
Study ID:
CS-059
NCT ID:
NCT01343693
Start Date:
June 2011
Completion Date:
February 2015
Related Keywords:
- DDD
- Deformity
- Tumor
- Fracture
- DDD
- Deformity
- Tumor
- Fracture
- Cervical
- Congenital Abnormalities
- Fractures, Bone
Name | Location |
|---|---|
| LSU Health Sciences Center | Shreveport, Louisiana 71130-3932 |
| Montgomery Spine Center | Montgomery, Alabama 36116 |
| Community Neurosurgery | Indianapolis, Indiana 46219 |
| Maryland Spine and Brain | Annapolis, Maryland 21401 |
| Dr. John T. Houten | Bronx, New York 10467 |
| Cary Orthopedics | Cary, North Carolina 27518 |
| DFW Center for Spinal Disorders | Fort Worth, Texas 76107 |
