Interested medical professionals can read through the full paper, as published in the International Journal of Spine Surgery, here.
The purpose of this study is to describe the mechanical durability and the clinical and radiographic outcomes of a viscoelastic total disc replacement (VTDR). The human intervertebral disc is a complex, viscoelastic structure, permitting and constraining motion in 3 axes, thus providing stability. The ideal disc replacement should be viscoelastic and deformable in all directions, and it should restore disc height and angle.
Mechanical testing was conducted to validate the durability of the VTDR, and a clinical study was conducted to evaluate safety and performance. Fifty patients with single-level, symptomatic lumbar degenerative disc disease at L4-5 or L5-S1 were enrolled in a clinical trial at 3 European sites. Patients were assessed clinically and radiographically for 2 years by the Oswestry Disability Index (ODI), a visual analog scale (VAS), and independent radiographic analyses.
The VTDR showed a fatigue life in excess of 50 million cycles (50-year equivalent) and a physiologically appropriate level of stiffness, motion, geometry, and viscoelasticity. We enrolled 28 men and 22 women in the clinical study, with a mean age of 40 years. Independent quantitative radiographic assessment indicated that the VTDR restored and maintained disc height and lordosis while providing physiologic motion. Mean ODI scores decreased from 48% preoperatively to 23% at 2 years’ follow-up. Mean VAS low-back pain scores decreased from 7.1 cm to 2.9 cm. Median scores indicated that half of the patient population had ODI scores below 10% and VAS low-back pain scores below 0.95 cm at 2 years.
The VTDR has excellent durability and performs clinically and radiographically as intended for the treatment of symptomatic lumbar degenerative disc disease.
The VTDR is intended to restore healthy anatomic properties and stability characteristics to the spinal segment. This study is the first to evaluate a VTDR in a 50-patient, multicenter European study.
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 exposure. He sees a niche opportunity where medicine, business and info. tech meet – and is uniquely educated at the intersection of these three professions. He has experience as Professor of Clinical Biomedical Sciences & Admissions Committee Member at the Charles E. Schmidt College of Medicine at Florida Atlantic University, Professor of Clinical Orthopedic Surgery at the Herbert Wertheim College of Medicine at Florida International University, Assistant Professor of Orthopaedics at the University of Pennsylvania Medical School, Visiting Spine Surgeon & Professor at the University of the West Indies, Mona, and Adjunct Professor of Clinical Biomedical Sciences at the University of Technology, Jamaica.
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The above study utilized LES Technology from SpineFrontier – leading provider of LES Technologies and instruments – offering surgeons and patients superior technology and services.
SCIENTIFIC PAPER AUTHOR AND CITATION DETAILS
Center of Orthopaedic and Spine Surgery, Zurich, Switzerland.
Hope Hospital, Manchester, UK.
Magdeburg Hospital, Magdeburg, Germany.
AxioMed Spine Corporation, Garfield Heights, OH.