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 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.
The LES Society philosophy: “Tailor treatment to the individual aiding in the quickest recovery and return to a pain-free lifestyle, using LES® techniques that lessen exposure, preserve unoffending anatomy and utilize new technologies which are safe, easy to adopt and reproducible. These LES®techniques lessen blood loss, surgical time and exposure to radiation and can be safely performed in an outpatient center. Less is more.” – Kingsley R. Chin, MD
About The LESS Institute
The LESS Institute is the world leader center of excellence in Less Exposure Surgery. Our safe, effective outpatient treatments help patients recover quickly, avoid expensive hospital stays and return home to their family the same day. Watch our patient stories, follow us on Facebook and visit TheLESSInstitute.com to learn more.
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.