Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data

Patient Safety in Surgery - Tập 11 - Trang 1-9 - 2017
Andreas Kotsias1,2, Sven Mularski3, Björn Kühn3, Michael Hanna4, Olaf Suess2,3
1Department of Orthopaedics and Traumatology, Helios Klinikum Emil von Behring, Berlin, Germany
2Department of Neurosurgery, Charité University Hospital, Berlin, Germany
3Spine and Neurotrauma Center, DRK Kliniken Westend, Berlin, Germany
4Mercury Spine Healthcare Consulting, New York, USA

Tóm tắt

Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment. Several types of intervertebral spacers can be used, but there is increasing evidence that PEEK cages yield insufficient fusion and thus less clinical improvement. The study aim was to assess the outcomes of single-level ACDF with an empty PEEK cage partially coated with titanium. This prospective multicenter single-arm clinical study collected follow-up data at 6, 12, and 18 months. A post hoc comparison was made to closely matched patients from another similar trial treated with identically designed, empty, uncoated PEEK cages. There were 49 of 50 patients (98%) who met the MCID of 3+ points of improvement on VAS pain or had an 18-month VAS ≤ 1. Yet even by 18 months post-op, only 40 of 50 (80%) PEEK + Ti patients achieved complete bony fusion. The PEEK + Ti group (n = 49) seemed to have somewhat better fusion scores and significantly better pain relief at 6 M than the matched controls (n = 49), but these differences did not persist at 12 M or 18 M. Patients (with either implant) who achieved complete bony fusion had significantly better improvement of pain at 6 M and disability at 6 M and 12 M than patients that remained unfused. ACDF is effective treatment for cervical myelopathy and radiculopathy. Although this and other studies show that titanium fuses better, partial coating of a PEEK cage does not improve the fusion rate sufficiently or confer other lasting clinical benefit. PEEK cages fully coated with titanium should be tested in prospective randomized comparative trials. Prospective, multicenter, single-arm clinical observational study without an individual Trial registration number. Study design and post hoc data analysis according to the “PIERCE-PEEK study”, ISRCTN42774128 , retrospectively registered 14 April 2009.

Tài liệu tham khảo

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