Medical Papers Total Disc Replacement

Clinical Experience and Two Year Follow up With a One-Piece Viscoelastic Cervical Total Disc Replacement

By Dr. Kingsley Chin

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Scientific Paper

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 AxioMed Freedom Cervical Disc

The AxioMed Freedom Cervical Disc

Background

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.

Methods

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..

Results

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 [20] and female [19] 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.

Lateral flexion and extension X-rays of TDR at C6/C7 at 2 years. TDR, total disc replacement.

Lateral flexion and extension X-rays of TDR at C6/C7 at 2 years. TDR, total disc replacement.

Lateral flexion and extension X-rays of TDRs at C5/C6 and C6/C7 at 1 year. TDR, total disc replacement.

Lateral flexion and extension X-rays of TDRs at C5/C6 and C6/C7 at 1 year. TDR, total disc replacement.

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Conclusions

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, Founder of philosophy and practice of The LES Society and The LESS Institute

Dr. Kingsley R. Chin, Founder of philosophy and practice of The LES Society and The LESS Institute

Dr. Kingsley R. Chin, Founder of philosophy and practice of The LES Society and The LESS Institute

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.

Learn more about Dr. Chin here and connect via LinkedIn.

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.

Scientific Paper Author & Citation Details

Authors

Kingsley Richard Chin¹, Jacob Ryan Lubinski¹, Kari Bracher Zimmers¹, Barry Eugene Sands², Fabio Pencle³

Author information

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: kzimmers@axiomed.com

Preclinical and Clinical Experience with a Viscoelastic Total Disc Replacement

By Dr. Kingsley Chin

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Scientific Paper

Rischke B1, Ross RS2, Jollenbeck BA3, Zimmers KB4, Defibaugh ND4.

Interested medical professionals can read through the full paper, as published in the International Journal of Spine Surgery, here.

Background 

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.

Methods

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.

Results

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.

Conclusions

The VTDR has excellent durability and performs clinically and radiographically as intended for the treatment of symptomatic lumbar degenerative disc disease.

Clinical Relevance

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, Founder of philosophy and practice of The LES Society and The LESS Institute

Dr. Kingsley R. Chin, Founder of philosophy and practice of The LES Society and The LESS Institute

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.

Learn more about Dr. Chin here and connect via LinkedIn.

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.

About SpineFrontier

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

Authors

Rischke B1, Ross RS2, Jollenbeck BA3, Zimmers KB4, Defibaugh ND4.

Author information

  1. Center of Orthopaedic and Spine Surgery, Zurich, Switzerland.

  2. Hope Hospital, Manchester, UK.

  3. Magdeburg Hospital, Magdeburg, Germany.

  4. AxioMed Spine Corporation, Garfield Heights, OH.

The Prevalence of Indications and Contraindications to Cervical Total Disc Replacement

By Dr. Kingsley Chin

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Scientific Paper

Auerbach JD1, Jones KJFras CIBalderston JRRushton SAChin KR.

Interested medical professionals can read through the full paper, as published in the Spine Journal, here.

Background Context

Although the prevalence of indications and contraindications to lumbar total disc replacement (TDR) has been evaluated, no study to date has quantified the potential candidacy for cervical disc replacement in practice.

Purpose

To report the potential candidacy rate for cervical TDR from both an academic and private practice spine surgery setting.

Study Design/Setting

Retrospective case series.

Patient Sample

Patient record review of 167 consecutive patients who underwent cervical spine surgery by 1 of 2 orthopedic spine surgeons between January 1, 2003 and January 1, 2005.

Outcome Measures

Evaluation of potential candidacy for cervical TDR, with emphasis on both contraindications and indications.

Methods

In this study, we used the published contraindications and indications listed in trials of four different cervical disc arthroplasty devices: ProDisc-C (Synthes Spine, West Chester, PA), PRESTIGE LP (Medtronik Sofamor Danek, Memphis, TN), Bryan Cervical Disc prosthesis (Medtronik Sofamor Danek, Memphis, TN), and Porous Coated Motion (PCM; Cervitech, Rockaway, NJ). The proportion of patients who met both inclusion and exclusion criteria was calculated. We also examined the proportion of patients who would be candidates for cervical TDR if the indications were expanded to include the treatment for adjacent segment disease (ASD).

Results

Of the 167 patients (mean age 50.8 years, range 20-89 years) reviewed, 91.6% (153/167) had fusion surgery and 8.4% (14/167) had nonfusion surgery. Fifty-seven percent (95/167) had absolute contraindications to cervical TDR, and within this group the average number of contraindications was 2.1 (SD=1.2, range 0-5). Forty-three percent (72/167) met the strict inclusion criteria, and had no exclusion criteria. If the indications were expanded to include treatment for ASD, an additional 4.2% (7/167) of the patients would have qualified as candidates for cervical TDR.

Conclusions

Compared with lumbar TDR, total disc replacement may have a larger potential role in the treatment of cervical degenerative conditions, as 43% of patients would have met the strict criteria for TDR candidacy, or 47% if the indications were expanded to include treatment for ASD.

Dr. Kingsley R. Chin, Founder of philosophy and practice of The LES Society and The LESS Institute

Dr. Kingsley R. Chin, Founder of philosophy and practice of The LES Society and The LESS Institute

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 Studies at the University of Technology, Jamaica.

Learn more about Dr. Chin here and connect via LinkedIn.

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.

About SpineFrontier

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 & Citation Details

Authors

Auerbach JD1, Jones KJFras CIBalderston JRRushton SAChin KR.

Author information

  1. Department of Orthopaedic Surgery, The Hospital of The University of Pennsylvania, Philadelphia PA, 19104, USA.