Transcript A Clinical Review of Cervical and Lumbar Arthroplasty

A CLINICAL REVIEW OF CERVICAL AND
LUMBAR ARTHROPLASTY
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PART I: CERVICAL ARTHROPLASTY
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Course Objectives
1. Identify Causes of Cervical Pain
2. Identify Treatment Options
3. Highlight of Clinical Data for Cervical Arthroplasty
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OBJECTIVE 1:
IDENTIFY CAUSES OF CERVICAL PAIN
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Neck Pain and Radiculopathy
 Neck pain is a common reason for visiting a doctor
• Over 6 million patient visits per year in the US for neck pain
• Represents 1.5 % of all health care visits to hospitals and physician
offices 1
 Main causes of neck pain
• Soft Tissue Strain
• Fractures
• Facet Joints
• Cervical Disc Disorders
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Neck Pain and Radiculopathy
 Pain can be accompanied by numbness in the neck and
or arms and can limit daily activities/ability to work
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Degenerative Disc Disease (DDD)
 Natural process that
ultimately affects all
of us as we age
• Nucleus Dehydrates
• Loss of Disc Height
• Annulus Cracks /Tears
• Daily activities or
trauma can accelerate
the degenerative
process
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OBJECTIVE 2:
IDENTIFY TREATMENT OPTIONS
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Treatment Options: Conservative Care
 In most cases, DDD responds to conservative care
• Physical Therapy
• Chiropractic Care
• Spinal Injections
• Bed Rest
• Bracing
• Analgesics / NSAIDS
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Treatment Options: Conservative Care
 If the disability or pain is
non-responsive to
conservative care, surgery
may be considered
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Treatment Options: Surgery
 The primary goal of surgery is decompression of the
neural structures
• Reduce pressure on spinal nerves or spinal cord
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Treatment Options: Surgery
 The surgeon must stabilize or reconstruct the spine
after decompression
• Option 1: Anterior Discectomy with Fusion (ACDF)
• Option 2: Total Disc Replacement /Spinal Arthroplasty (TDR)
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Treatment Options: Fusion (ACDF)
 Traditionally, ACDF is the procedure of choice
• 50 years of clinical experience
• Widely accepted technique
 The goal of ACDF is to fuse two vertebrae, stabilize the
spine, and prevent motion
 Fusion is very successful, with fusion rates typically
above 90% 2
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Clinical Disadvantage of ACDF
Fusion Success May Not Always Equal Clinical Success
 Adjacent level disease
• 25.9% of cervical fusion patients
predicted to have second surgery
within 10 years 3
 Hardware (plate and screws) may
impact adjacent levels
• 23.7% of ACDF patients developed
moderate to severe ossification at
adjacent level 4
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Clinical Disadvantage of ACDF
 Adjacent level will compensate for loss of motion at
fused level
• Fusion causes increased compensation at the adjacent segments,
which is postulated to accelerate the degenerative process 5
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Treatment Options: TDR
 TDR is a Newer Procedure Compared to ACDF
• 20+ years of clinical experience with TDR in the cervical spine
 Like total joint replacement procedures, TDR uses a
mobile implant to restore stability and allow the
potential for motion
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Treatment Options: TDR
 Rationale for TDR
• Restore Mechanical Stability Following Decompression
• Maintain Disc Height
• Decelerate Adjacent Level Degeneration
• Allow Potential For Motion
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TDR vs ACDF
TDR
Anterior Cervical Approach
Neural Decompression
In or Out Patient
Stabilize Operative Site
Restore Disc Height
Allow Potential for Motion
Potential To Slow the Rate of Adjacent-Level Disease
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ACDF
FDA Approved TDR Devices
Prestige-ST ® (Medtronic, approved 2007)
PRODISC® C (DePuy Synthes Spine, approved 2007)
Bryan ® (Medtronic, approved 2009)
PCM ® (NuVasive, approved 2012)
Secure-C ® (Globus, approved 2012)
Mobi-C ® (LDR, approved 2013)
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Cervical TDR Indications and Contraindications
 Indications
• Skeletally Mature
• One Symptomatic Disc (C3-C7)
• Neck or Arm Pain for at Least 6 Weeks that has Not Responded to
Conservative Care
 Contraindications
•
•
•
•
•
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Active Infection
Osteoporosis or Osteopenia
Allergies or Sensitivity to Implant Material
Instability
Clinically Compromised Vertebral Bodies at the Affected Level due to
Current or Past Trauma
OBJECTIVE 3:
HIGHLIGHT OF CLINICAL DATA FOR
CERVICAL ARTHROPLASTY
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TDR Clinical Evidence
Comparison of BRYAN Cervical Disc Arthroplasty with
Anterior Cervical Decompression and Fusion
Heller, et al (Spine 2009, V34, No2, 101-107) 6
463 patients
TDR had a higher rate of success
TDR patients returned to work 13 days earlier
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TDR Clinical Evidence
Clinical and Radiographic Analysis of Cervical Disc
Arthroplasty Compared with Allograft Fusion
Mummaneni, et al, (J Neurosurg Spine 2007, V6 198-209) 7
541 patients
TDR was found to be equivalent or superior to ACDF
ACDF group had 4.5 times more reoperations than the TDR group
TDR patients returned to work 16 days earlier
TDR patients return to work at a statistically significantly higher
rate compared to the ACDF patients
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TDR Clinical Evidence
Long-term Clinical and Radiographic Outcomes of
Cervical Disc Replacement with the Prestige Disc
Burkus, et al (J Neuosurg Spine 13, 301-318, 2010) 8
144 patients
TDR patients had statistically significant differences in NDI scores
TDR patients demonstrated higher neurologic success
Revision rates were statistically significantly lower for TDR patients
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TDR Clinical Evidence
Results of the PRODISC® C TDR Versus ACDF for the
Treatment of 1-Level Symptomatic Cervical Disc Disease
Murrey, et al (Spine Journal 2009, V9, 275-286) 9
209 patients
TDR patients had a statistically significant reduction in the use of
strong medications (narcotics or muscle relaxants)
PRODISC® C is a safe and effective surgical treatment for patients
with disabling cervical radiculopathy
By all primary and secondary measures evaluated, TDR was found
to be equivalent or superior to ACDF
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TDR Clinical Evidence
Five-year Reoperation Rates, Cervical Total Disc
Replacement Versus Fusion
Delamarter, et al (SPINE Volume 38, Number 9, pp 711–717) 10
209 patients
5 times more re-operations in the ACDF group (2.9% vs. 14.5%)
56% of the ACDF reoperations were for adjacent level disease
(ALD)
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TDR Clinical Evidence
PRODISC® C and ACDF as Surgical Treatment for Single
Level SDDD Five-year Results
Zigler, et al (SPINE Volume 38, Number 3, pp 203–209) 11
209 patients
Mean ROM at index level was maintained at 8.14 compared to
8.49 pre-op
Patient satisfaction was maintained as indicated on VAS
Statistically significant improvement of neck pain intensity and
frequency
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QUESTIONS?
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PART II: LUMBAR ARTHROPLASTY
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Course Objectives
1. Identify Causes of Lumbar Pain
2. Identify Treatment Options
3. Highlight of Clinical Data for Lumbar Arthroplasty
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OBJECTIVE 1:
IDENTIFY CAUSES OF LUMBAR PAIN
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Lumbar Pain
 Affects about 80% of the US
population 12
 Only outnumbered by the
common cold in absenteeism
from work
 Only a small percentage of cases
ultimately require surgery
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Causes of Lumbar Pain
 Most commonly, back pain is caused by muscle strain
 Back pain can also be caused by degenerative
conditions or trauma
• Spinal Stenosis
• Osteoarthritis
• Bone Fractures
• Osteomyelitis
• Spondylolisthesis
• Degenerative Disc Disease (DDD)
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Causes of Lumbar Pain
 Disc degeneration or traumatic injury can damage the
outer layers of the disc (annulus)
 Annulus may weaken or tear, allowing the inner disc
material (nucleus) to herniate
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Causes of Lumbar Pain
 Disc degeneration and or herniation can cause:
• Spinal Cord or Nerve Root Compression
• Neurologic Impairment
• Axial Back Pain
• Radicular Pain
• Injury of the Disc Can Impact Spine
• Function and Lead to Further
• Degeneration (Degenerative Cascade)
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Degenerative Cascade
Loss of Disc Height
Loss of Motion
Change in Spinal Balance
Formation of Osteophytes
Increased Load on the
Facets/Ligaments
Impingement on Spinal Cord
or Nerves
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OBJECTIVE 2:
IDENTIFY TREATMENT OPTIONS
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Treatment Options: Conservative Care
 In most cases, back pain responds to conservative care
• Physical Therapy
• Chiropractic Care
• Spinal Injections
• Bed Rest
• Bracing
• Analgesics / NSAIDS
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Treatment Options: Conservative Care
 If the disability or pain is non-responsive to
conservative care, surgery may be considered
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Treatment Options: Surgery
 The primary goal of surgery is to remove pain
generators and restore disc height
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Treatment Options: Surgery
 The surgeon must stabilize or reconstruct the spine
after decompression
• Option 1: Lumbar Fusion (posterior, lateral or anterior)
• Option 2: Total Disc Replacement /Spinal Arthroplasty (TDR)
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TDR vs Lumbar Fusion
TDR
Neural Decompression
Remove Pain Generators
Restore Disc Height
Stabilize Operative Site
Restore Spinal Balance
Allow Potential for Motion
Potential To Slow the Rate of Adjacent-Level Disease
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FUSION
TDR vs Lumbar Fusion
 Approach Options
• TDR is performed through an anterior approach only
• Fusion can be performed through a posterior, posterolateral, lateral
and/or anterior approach
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FDA Approved TDR Devices
PRODISC® L (DePuy Synthes Spine, approved 2006)
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Lumbar TDR Indications and Contraindications
 Indications
•
•
•
•
Skeletally Mature
DDD at One Level from L3 to S1
No More than Grade 1 Spondylolisthesis at the Involved Level
Failed at Least 6 Months of Conservative Treatment
 Contraindications
•
•
•
•
•
•
•
•
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Active Systemic Infection
Osteoporosis or Osteopenia
Boney Lumbar Spinal Stenosis
Allergies or Sensitivity to Implant Material
Isolated Radicular Compression Syndromes
Pars Defect
Lytic Spondylolisthesis or Degenerative Spondylolisthesis of Grade > 1
Clinically Compromised Vertebral Bodies at the Affected Level due to
Current or Past Trauma
OBJECTIVE 3:
HIGHLIGHT OF CLINICAL DATA FOR LUMBAR
ARTHROPLASTY
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TDR Clinical Evidence
Results of PRODISC® L TDR Versus the Circumferential
Fusion for the Treatment of 1-Level DDD
Zigler, et al (SPINE 2007, V32, NO11, 1155-1162) 13
286 patients
97% follow-up rate
In properly chosen patients, PRODISC® L has been shown to be
superior to circumferential fusion by multiple clinical criteria
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TDR Clinical Evidence
Maverick TDR Versus Anterior Lumbar Interbody Fusion
with the INFUSE Bone Graft / LT-CAGE Device
Gornet, et al (The Spine Journal Volume 7, Issue 5, Supplement , Page 1S, September 2007) 14
577 patients
TDR had statistical superiority over fusion at all follow-up intervals
for ODI, SF-36 PCS, back pain scores, and patient satisfaction with
surgery
TDR patients tend to return to work sooner than fusion patients
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TDR Clinical Evidence
Five-year Results PRODISC® L Versus Circumferential
Arthrodesis for the treatment of single-level DDD
Zigler, et al (J Neurosurg: Spine. October 19, 2012) 15
286 patients
TDR demonstrated equivalent clinical outcomes and non-inferiority
compared to spinal fusion at both 2 & 5 years
Improvement in ODI, VAS Pain, SF-36, neurologic function, and decrease
in narcotic use were maintained at 5 years in TDR patients
TDR had a lower overall reoperation rate at 5 years compared with
fusion
Average range of motion of 7.2 degrees was maintained at 5 years
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TDR Clinical Evidence
Five-Year Adjacent-level Degenerative Changes in
Patients Treated Using PRODISC® L Versus Fusion
Zigler, et al (J Neurosurg Spine. 2012 Dec; 17(6):504-11) 16
286 patients
Fusion patients were 3 times more likely to experience ALD than
were the TDR patients.
Changes in ALD at 5 years were observed in 9.2% of TDR patients
and 28.6% of fusion patients (p = 0.004).
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Summary
 Neck and Back Pain affects 80-90% of the US
population 17
 Most patients improve with conservative care
 Surgery may be considered if pain and disability are
non-responsive to conservative treatment
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Summary
 The Primary goal of surgery for these patients is to
decompress neural structures, restore neurologic
function and eliminate pain
 Fusion and Total Disc Replacement have been
discussed here as safe and affective surgical options
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Summary
The studies sited here have shown that TDR patients
Were more satisfied
Returned to work more quickly
Required fewer reoperations
Had lower incidence of Adjacent Level Disease
Maintained greater range of motion
When Compared to Fusion patients
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QUESTIONS?
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References
Reference
Author
Source
Title
1
NA
The Burden of Musculoskeletal Diseases in the United
States 2011
Spine: Low Back and Neck Pain - Chapter 2
2
Fraser et al
J Neurosurg Spine 6:298-303, 2007
Anterior approaches to fusion of the cervical spine: a meta-analysis of fusion rates
2
Mummaneni et al J Neurosurg Spine 2007, V6, 198-209
Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft Fusion: A
Randomized Controlled Clinical Trial
2
Murrey et al
Spine Journal 2009, V9, 275-286
Results of the Prospective, Randomized, Controlled, Multicenter Food and Drug Administration
Investigational Device Exemption Study of the PRODISC® C Total Disc Replacement Versus Anterior
Discectomy and Fusion for the Treatment of 1-Level Symptomatic Cervical Disc Disease
3
Hilibrand et al
J Bone Joint Surg Am. 1999 Apr;81(4):519-28.
Radiculopathy and Myelopathy at Segments Adjacent to the Site of a Previous Cervical Arthrodesis
4
Park et el
J Bone Joint Surg Am. 2005 Mar;87(3):558-63.
Development of adjacent-level ossification in patients with an anterior cervical plate
5
Schwab et al
SPINE Volume 31, Number 21, pp 2439–2448 2006
Motion Compensation Associated With Single-Level Cervical Fusion: Where Does the Lost Motion Go?
6
Heller et al
SPINE Volume 34, Number 2, pp 101–107 ©2009,
Lippincott Williams & Wilkins
Comparison of BRYAN Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion
7
Mummaneni et al J Neurosurg Spine 2007, V6, 198-209
Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft Fusion: A
Randomized Controlled Clinical Trial
8
Burkus et al
J Neurosurg Spine 13:308–318, 2010
Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: Results
from a prospective randomized controlled clinical trial
9
Murrey et al
Spine Journal 2009, V9, 275-286
Results of the Prospective, Randomized, Controlled, Multicenter Food and Drug Administration
Investigational Device Exemption Study of the PRODISC® C Total Disc Replacement Versus Anterior
Discectomy and Fusion for the Treatment of 1-Level Symptomatic Cervical Disc Disease
DJ 5895-C Norton 2-2013
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References
Reference
Author
Source
Title
10
Delamarter et al
SPINE Volume 38, Number 9, pp 711–717 2013
Five-year Reoperation Rates, Cervical Total Disc Replacement versus Fusion: Results of a Prospective
Randomized Clinical Trial
11
Zigler et al
SPINE Volume 38, Number 3, pp 203–209
PRODISC® C and ACDF as Surgical Treatment for Single Level Cervical Symptomatic Degenerative Disc
Disease: Five-Year Results of an FDA Study. Spine
12
Viscogliosi Bros
Spine Industry Analysis Series
Future of Spine Surgery “Beyond Total Disc”
13
Zigler et al
SPINE 2007, V32, No11, 1155-1162
Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device
Exemption Study of the PRODISC® L Total Disc Replacement Versus the Circumferential Fusion for the
Treatment of 1-Level Degenerative Disc Disease
14
Gornet et al
NASS 2007 / The Spine Journal 7 (2007) 1S–163S
Maverick Total Disc Replacement versus Anterior Lumbar Interbody Fusion with the INFUSE Bone Graft /LTCAGE Device: A Prospective, Randomized, Controlled, Multicenter IDE Trial
15
Zigler et al
J Neurosurg: Spine. October 19, 2012.
Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational
device exemption study of the PRODISC® L total disc replacement versus circumferential arthrodesis for the
treatment of single-level degenerative disc disease
16
Zigler et al
J Neurosurg Spine. 2012 Dec;17(6):504-11
Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar
total disc replacement with PRODISC® L versus circumferential fusion
17
Viscogliosi Bros
Spine Industry Analysis Series
Future of Spine Surgery “Beyond Total Disc”
DJ 5895-C Norton 2-2013
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