SECURE-C is intended for disc reconstruction and motion preservation at the disc under operation. The Investigational Device Exemption trial, inclusive of 380 patients, compared the SECURE-C to anterior cervical discectomy and fusion using a cervical plate and structural allograft. The patients suffered from intractable symptomatic cervical disc disease at a single level.
Here are seven-year, postsurgery data points:
1. Patients with the SECURE-C reported greater overall satisfaction compared to ACDF patients.
2. Of the SECURE-C group, 86.3 percent saw statistically superior composite overall success results compared to ACDF patients at 70 percent.
3. Eighty-six percent of the ACDF patients saw Neck Disability Index pain and function improvement compared to 90.4 percent of the SECURE-C group.
4. The SECURE-C patients experienced a lower rate of subsequent surgery at the operated level compared to ACDF patients.
5. ACDF patients had a higher rate of adjacent level surgery compared to SECURE-C patients.
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