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Centinel Spine in the News: New results “strongly support” the safety of the prodisc C device

prodisc-C-and-Fluoro-APPer Spinal News International:

At the annual meeting of the International Society for the Advancement of Spinal Surgery (3–5 April, Anaheim, USA), Jack E Zigler (Texas Health Center for Diagnostics and Surgery, Texas Back Institute, Plano, USA) reported results which “strongly support” the safety of the ProDisc-C device (Centinel Spine). In a study of 504 consecutive patients, Zigler and colleagues found that no secondary surgeries were required for device failure and a relatively low reoperation rate of 5.5%, including the learning curve for every participating surgeon.

The investigators report that secondary surgeries were required in 28/504 patients (5.5%). More specifically, 20/28 of these were operations for adjacent segment degeneration, five of which were adjacent to fusion levels. Three patients had total disc replacement (TDR) removals and anterior cervical discectomy and fusion (ADCF), including one migration, one subsidence, and one spondylosis. In addition, the investigators report one repositioning of a TDR, one incision and drainage for a wound infection, one haematoma drainage, two spinal cord stimulator implantations for pain control and, “most significantly,” according to Zigler, there were no reoperations for device failure.

Zigler and colleagues describe how cervical TDR cases involving the ProDisc-C device were identified at a multi-site, multi-surgeon spine speciality centre. They began with the first investigational device exemption (IDE) case performed in 2003 and included only patients ≥2 years postoperative by December 2017. Consecutive series of the first 504 ProDisc-C patients were analysed, involving 463 (92%) patients with one level, 39 patients (8%) with two levels, and two patients with three levels. The series included 112 hybrids…




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