Lightning Podiums: Spinal Gumbo - 803A
Presented by: M.F. Gornet
M.F. Gornet(1), K.D. Riew(2), T.H. Lanman(3), J.K. Burkus(4), S.D. Hodges(5), J.R. McConnell(6), R.F. Dryer(7), A.G. Copay(8), F.W. Schranck(8)
(1) The Orthopedic Center of St. Louis, St Louis, MO, United States
(2) Columbia University Medical Center, Dept of Orthopaedic Surgery, New York, NY, United States
(3) California Spine Group, Century City Hospital, Los Angeles, CA, United States
(4) Wilderness Spine Services, Columbus, OH, United States
(5) Center for Sports Medicine and Orthopedics, Chattanooga Outpatient Center, Chattanooga, TN, United States
(6) Orthopedic Associates of Allentown, Allentown, PA, United States
(7) Central Texas Spine Institute, Austin, TX, United States
(8) SPIRITT Research, St Louis, MO, United States
Purpose: While cervical disc arthroplasty (CDA) has been used for the treatment of cervical disc disease with radiculopathy or myelopathy, concerns remain about the appropriateness of CDA to treat patients with myelopathy. The objective of this study was to compare long-term safety and effectiveness outcomes after CDA in patients with myelopathy versus radiculopathy.
Methods: This is an analysis of prospectively collected 84-month outcomes data from an FDA IDE clinical trial comparing CDA to ACDF for the treatment of cervical disc disease at 2 adjacent levels. A total of 397 patients were enrolled with a diagnosis of radiculopathy, myelopathy, or both: 287 radiculopathy alone, and 110 myelopathy alone or myelopathy with radiculopathy. The outcome measures included 84-month safety and effectiveness
Outcomes: NDI, neck and arm pain (0-20 scale), SF-36 PCS, neurological status, adverse events, secondary surgeries at index and adjacent levels. Two comparisons were performed. First, CDA outcomes were compared between myelopathy (including myelopathy only and both myelopathy and radiculopathy) and radiculopathy patients. Second, the outcomes of CDA and ACDF were compared for myelopathy patients (including myelopathy only and both myelopathy and radiculopathy).
Results: There were no preoperative differences for the first comparison and the second comparison for NDI, neck and arm pain, and SF-36 PCS scores. All patient groups significantly improved for NDI, neck and arm pain, and PCS scores from preoperative to 84 months. First Comparison: At 84 months the myelopathy and radiculopathy groups showed similar improvement for NDI (37.8 vs 35.8, p=0.352; myelopathy vs radiculopathy, respectively), neck pain (12.0 vs 12.1, p=0.477), arm pain (11.6 vs 9.6, p=0.480), and PCS (14.1 vs 13.7, p=0.863). The two groups had similar proportions of patients who maintained or improved their neurological status (87.2% vs 93.5%, p=0.218), similar rates of serious adverse events (AEs) (54.5% vs 57.5%, p=0.291) and similar rates of secondary surgeries at index (3.7% vs 4.4%, p=0.839) and adjacent levels (3.7% vs 7.6%, p=0.367). Second Comparison: The CDA and ACDF groups showed similar improvement for NDI (37.8 vs 31.1, p=0.147; CDA vs ACDF, respectively), neck pain (12.0 vs 10.4, p=0.337), and arm pain (11.6 vs 11.4, p=0.791), PCS (14.1 vs 11.2, p=0.363). The two groups had similar proportions of patients who maintained or improved their neurological status (87.2% vs 96.2%, p=0.409) and similar overall rates of secondary surgeries at the index levels (3.7% vs 9.4%, p=0.374), and similar rates of secondary surgeries at adjacent levels (3.7% vs 15.4%, p=0.088). Compared to ACDF, the CDA group demonstrated lower rates of serious AEs (54.5% vs 65.9%, p=0.019).
Conclusions: Long-term results show that CDA is safe and effective for the treatment of myelopathy. Myelopathy patients gain similar improvement from CDA to patients with radiculopathy only. Furthermore, myelopathy patients report similar levels of improvement from CDA compared with ACDF, but suffer fewer serious AEs.