Update to the Treatment of Degenerative Cervical Disc Disease

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1 Update to the Treatment of Degenerative Cervical Disc Disease Michael Lynn, MD Neurosurgeon, Southeastern Neurosurgical & Spine Institute Adjunct Assistant Clinical Professor of Bioengineering, Clemson University

2 DISCLOSURE I have no direct or indirect financial interest in any pharmaceutical, medical device, or other health-care related company

3 Overview Cervical/neck pain is common reason for visiting doctor Over 6 million patient visits in the US for neck pain Represents 1.5 % of all health care visits to hospitals and physician offices (The Burden of Musculoskeletal Diseases in the United States) Main causes Soft tissue strain Degenerative arthritis Trauma Cervical disc disorders Pain can be accompanied by paraesthesias and weakness

4 It s a Natural Process Natural process that all people undergo as they age Nucleus dehydrates, compromising its cushioning ability Annulus may also begin to degenerate under the repeated stress of daily activities or trauma => disc herniation and loss of disc height

5 Treatment Options Non-surgical treatment physical therapy chiropractic care spinal injections bed rest bracing analgesics / NSAIDs Most patients improve without surgery If the disability/pain is non-responsive to conservative care, surgery may be considered

6 Surgical Treatment Decompression of neural structures to alleviate pressure Disc, bone, ligaments may be removed Removal of disc and bone creates instability between the two vertebrae Surgeon must stabilize, or reconstruct, the spine after decompression Option 1: anterior discectomy with fusion (ACDF) Option 2: total disc replacement (TDR)

7 Treatment Options: Fusion (ACDF) ACDF goal is to join two vertebrae together in a position that will stabilize the spine by preventing motion Traditionally, ACDF is procedure of choice 50 years of clinical experience Widely accepted technique Fusion rates very high with ACDF (90-97%)

8 Sequelae of ACDF Adjacent-level degeneration 25.9% of cervical fusion patients predicted to have second surgery within 10 years (Hilibrand,1999) Why? Adjacent level has to compensate loss of motion of fused level Extra motion fatigues adjacent disc and accelerates its degeneration (Schwab, 2006) Hardware (plate and screws) may impact adjacent levels 23.7% of ACDF patients developed moderate to severe ossification at adjacent level (Park, 2005) Natural History & Genetics

9 Treatment Options: Arthroplasty Arthroplasty - total disc replacement with artificial disc Rationale By allowing motion, adjacent level will not be overworked to compensate Early neck motion without bracing requirement Implant contained within disc space (limit damage to adjacent levels) Eliminate bone graft donor site complications and possible disease transmission from donor bone graft

10 Treatment Options: Arthroplasty Newer procedure 20 years of clinical experience with total disc replacement in the cervical spine

11 Indications Patient should be skeletally mature have only one or two symptomatic disc levels (C3-C7) have radiculopathy or neurologic deficit that has failed 6 weeks of conservative therapy

12 Contraindications Patient should not have any type of infection, especially infection in the spine and/or surrounding area osteoporosis or osteopenia (BMD T-score < -1.5) Trauma or other anatomic deformity (AS, RA) Biomechanical instability allergies or sensitivity to implant material

13

14 Old vs. New Fusion and arthroplasty both require same surgical approach Anterior Same approach-related risks Similar OR time The devices vary in placement technique and biomechanical components New is not always better Let s look at the evidence

15 Clinical Evidence 2007 Prospective, multi-center, randomized with two-year follow-up 541 patients randomized to disc or fusion 78% follow-up Re-ops: 5 discs, 23 fusion Results as good as or better compared to fusion Return to work rate statistically significantly higher in arthroplasty group than fusion group Mummaneni, et al. Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft Fusion: A Randomized Controlled Clinical Trial. J Neurosurg Spine 2007, V6,

16 2010 Clinical Evidence Prospective, multi-site, randomized clinical trial with 24-month follow-up and additional data at 36 and 60 months 144 patients with 60 month follow-up and 127 with fusion At both 36- and 60-month periods, differences in NDI scores statistically significant in favor of patients who received TDA Statistically higher rate of neurologic success compared to fusion at 24, 36 and 60 months Statistically significant lower revision and supplemental fixation rates for TDA versus fusion patients Burkus, et al. Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: Results from a prospective randomized controlled clinical trial. J Neurosurg Spine 13: , 2010

17 Clinical Evidence 2009 Prospective, multi-center, randomized with two-year follow-up 209 patients randomized to disc or fusion 8.5% of fusion patients needed a re-operation within the post-op period compared to 1.8% of TDA patients (p = 0.033) The results of this clinical trial demonstrate that [total disc arthroplasty] is a safe and effective surgical treatment for patients with disabling cervical radiculopathy By all primary and secondary measures evaluated, clinical outcomes after [total disc arthroplasty] implantation were either equivalent or superior to those same clinical outcomes after fusion. Murrey, et al. 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. Spine Journal 2009:

18 Adjacent Segment Disease February 2015 Meta-analysis of 8 prospective studies (1726 patients) ACDF patients 1.3x more likely to develop adjacent segment 2 years TDA patients 50% less likely to require adjacent segment 2 years Luo J 1, Gong M, Huang S, Yu T, Zou X. Incidence of adjacent segment degeneration in cervical disc arthroplasty versus anterior cervical decompression and fusion meta-analysis of prospective studies. Arch Orthop Trauma Surg Feb;135(2):

19 One vs. Two Levels March 2015 Multicenter Prospective RCT 164 one level; 225 two level Evaluation at four year follow-up No difference between one vs. two level TDA in NDI, VAS, adverse events, reoperations Bae HW 1, Kim KD, Nunley PD, Jackson RJ, Hisey MS, Davis RJ, Hoffman GA, Gaede SE, Danielson GO 3rd, Peterson DL, Stokes JM, Araghi A.. Comparison of Clinical Outcomes of One and Two-level Total Disc Replacement: 4-year Results from a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial. Spine (Phila Pa 1976) Mar 17. [Epub ahead of print]

20 Recent Meta-analysis January 2015 Analysis of 18 RCTs (4061 patients) TDA superior (P < ) Neurological improvement Motion preservation Need for repeat surgery at index level Fewer adverse events Rao MJ 1, Nie SP, Xiao BW, Zhang GH, Gan XR, Cao SS. Cervical disc arthroplasty versus anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease: a meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg Jan;135(1):19-28.

21 Recent Meta-analysis No significant difference: Operative blood loss (low overall) Length of stay (short overall) VAS Neck pain (low overall) VAS Arm pain (low overall) Rao MJ 1, Nie SP, Xiao BW, Zhang GH, Gan XR, Cao SS. Cervical disc arthroplasty versus anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease: a meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg Jan;135(1):19-28.

22 Case Study 40 yo right-handed male presents with left arm pain and weakness in his biceps and grip. Onset was 3 weeks prior to presentation, upon waking in the morning. He is gainfully employed, and although he works in management, occasionally will help out in the factory and lift heavy objects (> 50 lbs). He briefly tried chiropractic therapy. His symptoms do not respond to NSAIDs.

23 Case Study

24 Case Study Given his young age, unremarkable medical history, and healthy-appearing adjacent disc levels, a two-level total disc arthropasty or two-level ACDF was offered. He elected to pursue total disc arthroplasty.

25 Case Study

26 Case Study In the recovery room, his arm pain was completely relieved. Length of stay: 1 night. Return to work: Post-op day 11. On 2 week follow-up, he had residual numbness in his left thumb. On 6 week follow-up, he had no symptoms.

27 Thank you Michael Lynn, MD Neurosurgeon, Southeastern Neurosurgical & Spine Institute Adjunct Assitant Professor of Bioengineering, Clemson University 111 Doctors Drive Greenville, SC Tel:

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