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Pierce D. Nunley, Marcus B. Stone, Michael S. Hisey, Kee D. Kim, Robert J. Jackson, Hyun W. Bae, Gregory A. Hoffman, Steven E. Gaede, Guy O. Danielson III, Charles Gordon, Reginald J. Davis and Bimal Rami

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Reginald J. Davis, Pierce Dalton Nunley, Kee D. Kim, Michael S. Hisey, Robert J. Jackson, Hyun W. Bae, Gregory A. Hoffman, Steven E. Gaede, Guy O. Danielson III, Charles Gordon and Marcus B. Stone

OBJECT

The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up.

METHODS

A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the US. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.

RESULTS

At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.

CONCLUSIONS

Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels.

Clinical trial registration no.: NCT00389597 (clinicaltrials.gov)

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Pierce D. Nunley, Gregory M. Mundis Jr., Richard G. Fessler, Paul Park, Joseph M. Zavatsky, Juan S. Uribe, Robert K. Eastlack, Dean Chou, Michael Y. Wang, Neel Anand, Kelly A. Frank, Marcus B. Stone, Adam S. Kanter, Christopher I. Shaffrey, Praveen V. Mummaneni and the International Spine Study Group

OBJECTIVE

The aim of this study was to educate medical professionals about potential financial impacts of improper diagnosis-related group (DRG) coding in adult spinal deformity (ASD) surgery.

METHODS

Medicare’s Inpatient Prospective Payment System PC Pricer database was used to collect 2015 reimbursement data for ASD procedures from 12 hospitals. Case type, hospital type/location, number of operative levels, proper coding, length of stay, and complications/comorbidities (CCs) were analyzed for effects on reimbursement. DRGs were used to categorize cases into 3 types: 1) anterior or posterior only fusion, 2) anterior fusion with posterior percutaneous fixation with no dorsal fusion, and 3) combined anterior and posterior fixation and fusion.

RESULTS

Pooling institutions, cases were reimbursed the same for single-level and multilevel ASD surgery. Longer stay, from 3 to 8 days, resulted in an additional $1400 per stay. Posterior fusion was an additional $6588, while CCs increased reimbursement by approximately $13,000. Academic institutions received higher reimbursement than private institutions, i.e., approximately $14,000 (Case Types 1 and 2) and approximately $16,000 (Case Type 3). Urban institutions received higher reimbursement than suburban institutions, i.e., approximately $3000 (Case Types 1 and 2) and approximately $3500 (Case Type 3). Longer stay, from 3 to 8 days, increased reimbursement between $208 and $494 for private institutions and between $1397 and $1879 for academic institutions per stay.

CONCLUSIONS

Reimbursement is based on many factors not controlled by surgeons or hospitals, but proper DRG coding can significantly impact the financial health of hospitals and availability of quality patient care.