MaxAn Clinical Trial

Title: “A Post Market Surveillance Validation to Evaluate the Clinical Performance of the MaxAn® Anterior Cervical Plate System”

Study Sponsor: BHR Pharma, LLC

Principal Investigator: Christopher Rumana, MD

Study Synopsis: The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the MaxAn® Anterior Cervical Plate System.

The system offers a decompression-based technique for cervical spine stabilization and introduces an innovative one-level plate technique that provides a direct relationship between the bone graft/spacer size and the position of the plate holes. Subjects will be followed pre-operatively, intra-operatively and postoperatively at 6, 12 and 24 months. This post market surveillance study will enroll up to two hundred (200) subjects at up to 15 clinical centers within the United States with subjects followed for 24 months post-surgery.

Study Status: Open for enrollment.

For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115

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