11/8/2013 1 Cervical Total Disc Replacement Bobby KB Tay MD HS Clinical Professor Department of Orthopaedic Surgery University of California at San Francisco Director UCSF Spine Fellowship UCSF Spine Techniques Symposium Las Vegas, NV November 8, 2013 Disclosures Stryker Spine consultant, honoraria Synthes Spine honoraria Biomet Spine honoraria Fellowship support: OREF, AOA, AOSpine, Globus, Nuvasive Acknowledgements Jack Zigler MD Globus Spine LDR Spine
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11/8/2013
1
Cervical Total Disc Replacement
Bobby KB Tay MD
HS Clinical Professor
Department of Orthopaedic Surgery
University of California at San Francisco
Director UCSF Spine Fellowship
UCSF Spine Techniques Symposium
Las Vegas, NV
November 8, 2013
Disclosures
Stryker Spine consultant, honoraria
Synthes Spine honoraria
Biomet Spine honoraria
Fellowship support: OREF, AOA, AOSpine, Globus,
Nuvasive
Acknowledgements
Jack Zigler MD
Globus Spine
LDR Spine
11/8/2013
2
Courtesy of Gary Ghiselli MD
Materials and Fixation CTDR
Prestige ST(Medtronic)
Prodisc-C (Synthes)
Bryan (Medtronic)
PCM (Cervitech )
Secure-C (Globus)
Mobi-C (LDR)
Metal-on Metal
316 stainless steel
Cobalt-Chrome
UHMWPE
Polyurethane Center
titanium endplates
Flexible membrane
Cobalt-Chrome
UHMWPE
Cobalt-Chrome
UHMWPE
Screw fixation
Grit blast ingrowth
Keel Fixation.
Titanium Plasma Spray
Convex endplates
Titanium porous
coating
Serrated surface.
Titanium/calcium
phosphate coating
Mobile bearing
3 spikes
Titanium plasma spray
Semi-constrained
Semi-constrained
Semi-constrained
Semi-constrained
Semi-constrained
Unconstrained
Cobalt-Chrome
UHMWPE
Published IDE Clinical Trials
Prosthesis Company US Approval Last FU Data
Published from
RCTs
Prestige Medtronic July 17, 2007 JNSpine, Sep 2010
Prodisc-C Depuy-Synthes December 17,
2007
Spine J. 2009
Apr;9(4):275-86
Secure-C Globus September 18,
2012
Vaccaro et. Al, in
press
Bryan Medtronic Approved May12,
2009
J Spinal Disord
Tech. 2010
Aug;23(6):367-71
Mobi-C LDR August 7, 2013 In press
11/8/2013
3
Patient Selection Inclusion Criteria
Has cervical degenerative disc disease as defined as:
– intractable radiculopathy and/or myelopathy with at least one of the following items
producing symptomatic nerve root and/or spinal cord compression that is documented
by patient history:
• a) herniated disc;
• b) osteophyte formation
One level requiring surgical treatment
C3-C4 disc to C6-C7 disc level involvement
Unresponsive to non-operative treatment for six weeks or presence of progressive
symptoms or signs of cord compression
No previous surgical procedures at the involved level or any planned surgical procedure at
the involved or adjacent level.
Preop Neck Disability index score ≥ 30
Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire
Not pregnant at time of surgery
Willing and able to comply with study plan and able to understand and sign patient informed
consent
Contraindications to cTDR
Cervical instability (translation >3 mm and/or
>11° rotational difference to that or either
adjacent level)
Known allergy to implant materials (titanium,
polyethylene, cobalt, chromium, and
molybdenum)
Posttraumatic vertebral body
deficiency/deformity
Facet joint degeneration
Neck or arm pain of unknown etiology
Axial neck pain as the solitary presenting
symptom
Severe spondylosis (bridging osteophytes, disc
height loss >50%, and absence of motion
<2°)
Osteoporosis/osteopenia
Prior surgery at the level to be treated
Active malignancy; any patient with history of
invasive malignancy, unless treated and
asymptomatic for at least 5 years
Presently on medications that can interfere with
bone/soft tissue healing (ie, steroids)
Autoimmune spondyloarthropathies
(rheumatoid arthritis
Active local/systemic infection
Autoimmune spondyloarthropathies
(rheumatoid)
Pregnant
Other metabolic bone disease (ie, Paget's and
osteomalacia)
Morbid obesity (BMI>40 or weight>100 lb over
ideal body weight)
Adapted from Auerbach, Balderston , Spine Journal 2008