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A CLINICAL REVIEW OF CERVICAL AND LUMBAR ARTHROPLASTY

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PART I: CERVICAL ARTHROPLASTY

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1. Identify Causes of Cervical Pain

2. Identify Treatment Options

3. Highlight of Clinical Data for Cervical Arthroplasty

Course Objectives

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OBJECTIVE 1: IDENTIFY CAUSES OF CERVICAL PAIN

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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

Neck Pain and Radiculopathy

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Pain can be accompanied by numbness in the neck and or arms and can limit daily activities/ability to work

Neck Pain and Radiculopathy

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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

Degenerative Disc Disease (DDD)

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OBJECTIVE 2: IDENTIFY TREATMENT OPTIONS

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In most cases, DDD responds to conservative care• Physical Therapy

• Chiropractic Care

• Spinal Injections

• Bed Rest

• Bracing

• Analgesics / NSAIDS

Treatment Options: Conservative Care

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If the disability or pain is non-responsive to conservative care, surgery may be considered

Treatment Options: Conservative Care

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The primary goal of surgery is decompression of the neural structures

• Reduce pressure on spinal nerves or spinal cord

Treatment Options: Surgery

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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)

Treatment Options: Surgery

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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

Treatment Options: Fusion (ACDF)

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Fusion Success May Not Always Equal Clinical Success

Clinical Disadvantage of ACDF

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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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

Clinical Disadvantage of ACDF

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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

Treatment Options: TDR

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Rationale for TDR

• Restore Mechanical Stability Following Decompression

• Maintain Disc Height

• Decelerate Adjacent Level Degeneration

• Allow Potential For Motion

Treatment Options: TDR

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TDR ACDF

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

TDR vs ACDF

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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)

FDA Approved TDR Devices

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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

• 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

Cervical TDR Indications and Contraindications

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OBJECTIVE 3: HIGHLIGHT OF CLINICAL DATA FOR CERVICAL ARTHROPLASTY

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463 patients

TDR had a higher rate of success

TDR patients returned to work 13 days earlier

TDR Clinical EvidenceComparison of BRYAN Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion Heller, et al (Spine 2009, V34, No2, 101-107) 6

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Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft FusionMummaneni, et al, (J Neurosurg Spine 2007, V6 198-209) 7

TDR Clinical Evidence

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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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

TDR Clinical Evidence

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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

TDR Clinical Evidence

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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)

TDR Clinical Evidence

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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

TDR Clinical Evidence

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QUESTIONS?

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PART II: LUMBAR ARTHROPLASTY

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1. Identify Causes of Lumbar Pain

2. Identify Treatment Options

3. Highlight of Clinical Data for Lumbar Arthroplasty

Course Objectives

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OBJECTIVE 1: IDENTIFY CAUSES OF LUMBAR PAIN

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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

Lumbar Pain

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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)

Causes of Lumbar Pain

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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

Causes of Lumbar Pain

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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)

Causes of Lumbar Pain

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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

Degenerative Cascade

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OBJECTIVE 2: IDENTIFY TREATMENT OPTIONS

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In most cases, back pain responds to conservative care• Physical Therapy

• Chiropractic Care

• Spinal Injections

• Bed Rest

• Bracing

• Analgesics / NSAIDS

Treatment Options: Conservative Care

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If the disability or pain is non-responsive to conservative care, surgery may be considered

Treatment Options: Conservative Care

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The primary goal of surgery is to remove pain generators and restore disc height

Treatment Options: Surgery

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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)

Treatment Options: Surgery

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TDR FUSION

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

TDR vs Lumbar Fusion

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Approach Options

• TDR is performed through an anterior approach only

• Fusion can be performed through a posterior, posterolateral, lateral and/or anterior approach

TDR vs Lumbar Fusion

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PRODISC® L (DePuy Synthes Spine, approved 2006)

FDA Approved TDR Devices

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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• 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

Lumbar TDR Indications and Contraindications

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OBJECTIVE 3: HIGHLIGHT OF CLINICAL DATA FOR LUMBAR ARTHROPLASTY

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Results of PRODISC® L TDR Versus the Circumferential Fusion for the Treatment of 1-Level DDDZigler, 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

TDR Clinical Evidence

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Maverick TDR Versus Anterior Lumbar Interbody Fusion with the INFUSE Bone Graft / LT-CAGE DeviceGornet, 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

TDR Clinical Evidence

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Five-year Results PRODISC® L Versus Circumferential Arthrodesis for the treatment of single-level DDDZigler, 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

TDR Clinical Evidence

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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).

TDR Clinical Evidence

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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

Summary

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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

Summary

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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

Summary

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QUESTIONS?

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ReferencesReference 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, 275-286Results 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, 275-286Results 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

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ReferencesReference 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, 1155-1162Results 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 /LT-CAGE 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”