Kingsley Richard Chin, Jacob Ryan Lubinski, Kari Bracher Zimmers, Barry Eugene Sands, Fabio Pencle
Interested medical professionals can read through the full paper, as published in the Journal of Spine Surgery, here.
The purpose of this study is to present clinical outcome data from a 2-year post-market study of a viscoelastic one-piece cervical total disc replacement (TDR) in Europe.
Thirty-nine patients were implanted at five surgical sites in an European post-market clinical study. Clinical outcomes included improvement of neck disability index (NDI) and visual analog scale scores for neck and arm pain from baseline to 2-year follow-up, neurological examinations, patients view on the success of surgery, complications, and subsequent surgical interventions..
Thirty patients had the Freedom® Cervical Disc (FCD) implanted at a single level, and nine patients were implanted at two adjacent levels. The population had a similar distribution of male  and female  subjects, with a mean age of 45 years. All self-administered outcome measures showed significant clinically important improvements from baseline to the 2-year follow-up. Mean preoperative NDI score improved from 48% to 20%, 13%, 8%, 6% and 4% at 6 weeks, 3, 6, 12, and 24 months, respectively. Average preoperative visual analog scale (VAS) scores of the neck, right and left arm pain intensity and frequency showed significant improvement. All neurological outcome measurements showed immediate improvement from preoperative values and continued improvement throughout 2 years follow-up. From pre-op to 24 months, neurological deficits declined in the population from 21% to 6% for reflex function, 62% to 17% for sensory function, and 38% to 3% for motor function. No patients experienced a deterioration in any measured outcomes compared with the preoperative situation. Patient satisfaction increased over 2 years post-op, with 83% of patients responding that they would “definitely” choose to have the same treatment for their neck/arm condition and another 11% responding that they would “probably” choose to have the same treatment.
The FCD performs as expected in patients with single-level and two-level degenerative disc disease.
About Author Dr. Kingsley R. Chin
Dr. Kingsley R. Chin is a board-certified Harvard-trained orthopedic spine surgeon and professor with copious business and information technology experience. He sees a niche opportunity where medicine, business and information technology meet and is uniquely experienced at the intersection of these three professions. He currently serves as Professor of Clinical and Biomedical Sciences at the Charles E. Schmidt School of Medicine at Florida Atlantic University and Professor of Clinical Orthopaedic Surgery at the Herbert Wertheim College of Medicine at Florida International University and has experience as Assistant Professor of Orthopaedics at the University of Pennsylvania Medical School and Visiting Professor at the University of the West Indies.
About Less Exposure Surgery
Less Exposure Surgery (LES) is based on a new philosophy of performing surgery, leading the charge to prove through bench and clinical outcomes research that LES treatment options are the best solutions – to lowering the cost of healthcare, improving outcomes and increasing patient satisfaction. Learn more at LESSociety.org.
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Scientific Paper Author & Citation Details
Kingsley Richard Chin¹, Jacob Ryan Lubinski¹, Kari Bracher Zimmers¹, Barry Eugene Sands², Fabio Pencle³
¹AxioMed LLC, Malden, MA, USA; ²RQMIS, Inc. Amesbury, MA, USA; ³Less Exposure Surgery Society, Malden, MA, USA Contributions: (I) Conception and design: All authors; (II) Administrative support: KB Zimmers, BE Sands; (III) Provision of study materials or patients: BE Sands; (IV) Collection and assembly of data: BE Sands; (V) Data analysis and interpretation: BE Sands, KB Zimmers; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors. Correspondence to: Kari Bracher Zimmers. AxioMed LLC, Malden, MA, USA. Email: firstname.lastname@example.org