MaxAn Post Market Surveillance Validation

Completed

Conditions studied: DDD, Deformity, Tumor, Fracture

In brief

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.

Key facts

Study ID

NCT01343693

Run by

Zimmer Biomet

People needed

119

Starts

2011-06-01

Expected to finish

2018-01-01

Last updated by the study team

2020-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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