Lumbar Disc Arthroplasty vs. Anterior Lumbar Interbody Fusion: Five-Year Outcomes for Patients in the Maverick® Disc IDE Study

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Proceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S

treatment received. Forty baseline variables were used to define subgroups for calculating the time-weighted average TE for the ODI over 4 years (TE5DODIsurgery-DODInonoperative). Variables with significant subgroup* treatment interactions (p!0.1) were simultaneously entered into a multivariate model to select independent TE predictors. RESULTS: All analyzed subgroups improved significantly more with surgery than with nonoperative treatment (p!0.05). Joint problems, being single, education beyond high school, reporting an unchanging or improving health trend, age under 42, receiving worker’s compensation, and shorter duration of symptoms predicted smaller TEs. Multivariate analysis demonstrated that joint problems (TE -10.3 vs. -14.6 for patients without joint problems, p50.012), being single (TE -7.7 vs. -15.8 for married patients, p!0.001), and reporting an unchanging health trend (TE -11.8 vs. -15.9 for patients getting worse, p50.032) were independent TE modifiers. TEs ranged from -7.2 for single patients with no joint problems and unchanging health to -21.1 for married patients with no joint problems and worsening health. CONCLUSIONS: SPORT patients met specific inclusion criteria and improved more with surgery than with nonoperative treatment in all evaluated subgroups. However, TE varied significantly among subgroups; patients with joint problems, single patients, and those with an unchanging health trend had smaller TEs. The treatment of IDH is ‘‘preference sensitive’’, so patients meeting the strict inclusion criteria should be offered surgical or nonoperative treatment. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.

for all devices in previous IDE studies for lumbar disc arthroplasty. At each follow-up beyond 3 months, over 80% of investigational patients and over 70% of control patients reported an ODI improvement of at least 15 points, an FDA-defined measure of success. Statistical superiority over fusion was concluded for Maverick at all follow-up intervals up to and including 24 months for Oswestry (p50.004), SF-36 PCS (p50.009), back pain scores (p50.022), and patient satisfaction with surgery (p50.003). At 5 years, statistical superiority is concluded for Maverick mean improvements in ODI (p50.009), SF-36 PCS (p50.002) and patient satisfaction (p50.043). Neurological status was statistically equivalent in the two groups. Investigational patients returned to work 21 days sooner than control patients, which was statistically significant. At both 2 and 5 years after surgery, over 70% of patients in each group were working. At 5 years postop, 87.0% of the investigational patients said that they would have the surgery again, versus 82.7% for the control group (p50.190). Seven second surgeries in 4 additional patients occurred at the index level after 24 months in both the investigational group and in the control group, although more than twice as many investigational patients as control patients were followed. There was no second surgery after 36 months in the investigational group. CONCLUSIONS: Consistent with the 2-year IDE study outcomes, treatment of single-level lumbar degenerative disease with the Maverick Disc resulted in outstanding clinical outcomes at 5 years after surgery, including Oswestry and SF-36 PCS, resulting in improved physical function, reduced pain, and greater patient satisfaction. FDA DEVICE/DRUG STATUS: Maverick Disc: Investigational/Not approved.

doi: 10.1016/j.spinee.2010.07.173 doi: 10.1016/j.spinee.2010.07.174

140. Lumbar Disc Arthroplasty vs. Anterior Lumbar Interbody Fusion: Five-Year Outcomes for Patients in the MaverickÒ Disc IDE Study Matthew F. Gornet, MD1, Randall F. Dryer, MD2, John H. Peloza, MD3, Francine W. Schranck, BSN1; 1The Orthopedic Center of St. Louis, St. Louis, MO, USA; 2Central Texas Spine Institute, Austin, TX, USA; 3Center for Spine Care, Dallas, TX, USA BACKGROUND CONTEXT: The 2-year FDA IDE clinical trial of the MaverickÒ Disc was reported previously, demonstrating the clinical outcomes superiority of lumbar disc arthroplasty (LDA) using the Maverick Disc when compared with anterior interbody fusion (ALIF) with the INFUSEÒ Bone Graft/LT-CAGEÒ Device for patients with lumbar degenerative disease. PURPOSE: To present up to five-year interim outcomes for patients in the continuation of the Maverick IDE trial, while follow-up at 5 years is still ongoing. STUDY DESIGN/SETTING: A prospective, randomized (2:1), controlled study at 31 centers. PATIENT SAMPLE: 405 investigational (LDA) and 172 control (ALIF) patients with single-level disc disease (L4 to S1). Patient groups were similar in demographics and preoperative clinical measures. OUTCOME MEASURES: Self-reported measures including Oswestry Disability Index (ODI), SF-36, and back and leg pain numeric questionnaires, physiologic measures including neurological status, and functional measures including work status were assessed. Radiographic outcomes included disc height, index and adjacent level angular motion, and fusion success. METHODS: Statistical analysis based on patient measures collected preoperatively and at 1.5, 3, 6, 12, 24, 36 and 60 months post-op. RESULTS: Mean score improvement for key clinical outcome measures including ODI, SF-36 PCS, back pain and leg pain was statistically significant (p!0.001) versus pre-op for both groups at all follow-up intervals. ODI improvement was noteworthy for both the LDA (n5370/138) and ALIF (n5261/99) groups (LDA 33.8/34.9 points; ALIF 29.2/29.9 points) at 24/60 months respectively, surpassing reported mean ODI improvements

141. Correlation of Early Pain and Long-Term Functional Results from a Multi-Center, Prospective, Randomized, Controlled FDAIDE Vertebroplasty Trial Hyun W. Bae, MD1, Raymond Linovitz, MD2, Philip Maurer, MD3, Pierce Nunley, MD4, Michael Schaufele, MD5, Louis Gilula, MD6, Allan L. Brook, MD7, William Marx, MD8, Mubin I. Syed, MD9, Federico Girardi, MD10, David A. Tahernia, MD11, William Horsley, MD12; 1The Spine Institute, Santa Monica, CA, USA; 2 Core Orthopedic Medical Center, PC, Encinitas, CA, USA; 3Pennsylvania Hospital, Philadelphia, PA, USA; 4The Spine Institute of Louisiana, Shreveport, LA, USA; 5Emory Orthopaedics and Spine Center, Atlanta, GA, USA; 6Washington University Medical Center, St. Louis, MO, USA; 7 Montefiore Medical Center, Bronx, NY, USA; 8Mission Hospitals, Asheville, NC, USA; 9Radiology Physicians of Springfield, Kettering, OH, USA; 10Hospital for Special Surgery, New York, NY, USA; 11Desert Orthopedics Center, Ranch Mirage, CA, USA; 12Scottsdale Medical Imaging, Scottsdale, AZ, USA BACKGROUND CONTEXT: Vertebroplasty (PVP) was developed by Galibert and Deramond in 1984 and involves the percutaneous injection of augmentation material to immobilize and reinforce fractured vertebral bodies (VCFs). Over the past 25 years PVP has become the treatment of choice for acute painful fractures, however, prospective, randomized, comparative data that includes functional outcomes on the effects beyond 12 months after treatment are lacking. Advanced age of the patients and the prevalence of concomitant diseases are partially to blame, as they make the assessment of long term outcomes more difficult. PURPOSE: To present the long-term functional results observed in a multi-center trial comparing two materials used to treat osteoporotic VCFs: PMMA (P) and Cortoss TM (C), a bioactive material recently cleared by FDA. STUDY DESIGN/SETTING: A prospective, randomized, controlled study of vertebral augmentation comparing C and P in 256 patients, 162 C and 94 P. Follow-up was done at 7 days, 1, 3, 6, 12, and 24 months. This is the largest prospective study in VCFs on record.

All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.