MaxAn Post Market Surveillance Validation (MaxAn)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Zimmer Biomet.
Recruitment status was: Active, not recruiting
Information provided by (Responsible Party):
First received: April 27, 2011
Last updated: February 26, 2016
Last verified: September 2015
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate
Primary Outcome Measures:
- Disc Degeneration [ Time Frame: 24 Months ]
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
Secondary Outcome Measures:
- Change in Disc Height [ Time Frame: 24 Months ]
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 ]
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343693
|Montgomery Spine Center
|Montgomery, Alabama, United States, 36116 |
|Tallahassee Neurological Clinic
|Tallahassee, Florida, United States, 32308 |
|Indianapolis, Indiana, United States, 46219 |
|Maryland Spine and Brain
|Annapolis, Maryland, United States, 21401 |
|Cary, North Carolina, United States, 27518 |
|DFW Center for Spinal Disorders
|Fort Worth, Texas, United States, 76107 |
||Gary Dix, MD
||Maryland Spine and Brain
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 27, 2011
||February 26, 2016
|Individual Participant Data (IPD) Sharing Statement:
|Plan to Share IPD:
Keywords provided by Zimmer Biomet:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 21, 2017