A cervical "zero-profile" cage with integrated angle-stable fixation: 24-months results.
The purpose of this prospective mono-centric case series study is to investigate the mid-term (minimum follow-up 24 months) safety and efficacy using a new "zero-profile" stand-alone cage with integrated angle-stable fixation in single- and multilevel anterior cervical fusions. 53 consecutive patients with radiculopathy/myelopathy at one to three levels underwent an anterior cervical discectomy and fusion procedure using the "zero-profile" implant (97 levels operated). A CT-scan at 12-months was taken to assess fusion status, implant failure, subsidence and migration. The overall fusion rate was 97%. 3 out of 45 patients (6.6%) complained about mild dysphagia related symptoms at 24 months follow-up . There was no recorded incidence of hardware failure. The new cervical stand-alone anterior fusion device allows a safe anterior cervical decompression and stabilisation, a low rate of chronic dysphagia and achieves a high fusion rate. Prospective randomised trials are necessary to confirm these results.
Matti
M
Scholz
Sebastiaan
S
Schelfaut
Andreas
A
Pingel
Philipp
P
Schleicher
Frank
F
Kandziora
D000328:Adult; D000368:Aged; D002574:Cervical Vertebrae / Q000601:surgery*; D015331:Cohort Studies; D019299:Decompression, Surgical; D017586:Diskectomy / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019736:Prostheses and Implants; D011843:Radiculopathy / Q000601:surgery*; D013117:Spinal Cord Compression / Q000601:surgery*; D013123:Spinal Fusion / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome