Clinical trial NCT01343693: MaxAn Post Market Surveillance Validation
Official title: A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DDD
Deformity
Tumor
Fracture
Keywords: DDD
Deformity
Tumor
Fracture
Cervical
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Number of Participants With Differing Severity of Adjacent Level Ossification
timeFrame: 24 Months
Secondary outcomes:
measure: Change in Neck Disability Index (NDI)
timeFrame: 24 Months
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Montgomery Spine Center
state: Alabama
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Indianapolis
country: United States
facility: Community Neurosurgery
state: Indiana
city: Annapolis
country: United States
facility: Maryland Spine and Brain
state: Maryland
city: Cary
country: United States
facility: Cary Orthopedics
state: North Carolina
city: Fort Worth
country: United States
facility: DFW Center for Spinal Disorders
state: Texas
Study officials:
affiliation: Maryland Spine and Brain
name: Gary Dix, MD
role: PRINCIPAL_INVESTIGATOR
References: