Guy Matgé1, Peter Buddenberg2, Marcus Eif3, Holger Schenke3, Joerg Herdmann2. 1. National Neurosurgical Department, Centre Hospitalier de Luxembourg, 25 Rue de La Gare, Mamer, 8229, Luxembourg City, Luxembourg. matge@internet.lu. 2. Spine Unit and Center of Pain Management, St. Vinzenz Hospital, Düsseldorf, Germany. 3. Department of Neurosurgery, Municipal Clinic of Görlitz, Görlitz, Germany.
Abstract
PURPOSE: The dynamic cervical implant (DCI) is a novel motion-preserving concept for the treatment of degenerative cervical disorders. The aim of this prospective clinical study was to validate the concept and analyse clinical and radiological performance of the implant. MATERIALS/ METHODS: One hundred seventy-five consecutive patients with degenerative cervical disorders, median age, 47 years, were treated with discectomy and DCI, and followed for 2 years. Clinical outcome was evaluated with the Neck Disability Index (NDI), the SF-12, and visual analogue scale (VAS) assessment of arm and neck pain. Range of motion (ROM) and cervical alignment were analysed using radiographic imaging. RESULTS: All clinical outcome measures--VAS neck and arm pain, NDI, and SF-12 mental and physical component summaries--improved significantly after surgery (each p < 0.001) and remained stable over the whole observation period. The ROM (flexion/extension) at the level treated with DCI was slightly reduced, but no significant changes could be verified at the adjacent levels. Six surgery or device-related adverse events were documented during the study. CONCLUSIONS: Good clinical and excellent radiological outcomes demonstrate that DCI is a safe and efficient treatment option in patients with degenerative cervical disorders.
PURPOSE: The dynamic cervical implant (DCI) is a novel motion-preserving concept for the treatment of degenerative cervical disorders. The aim of this prospective clinical study was to validate the concept and analyse clinical and radiological performance of the implant. MATERIALS/ METHODS: One hundred seventy-five consecutive patients with degenerative cervical disorders, median age, 47 years, were treated with discectomy and DCI, and followed for 2 years. Clinical outcome was evaluated with the Neck Disability Index (NDI), the SF-12, and visual analogue scale (VAS) assessment of arm and neck pain. Range of motion (ROM) and cervical alignment were analysed using radiographic imaging. RESULTS: All clinical outcome measures--VAS neck and arm pain, NDI, and SF-12 mental and physical component summaries--improved significantly after surgery (each p < 0.001) and remained stable over the whole observation period. The ROM (flexion/extension) at the level treated with DCI was slightly reduced, but no significant changes could be verified at the adjacent levels. Six surgery or device-related adverse events were documented during the study. CONCLUSIONS: Good clinical and excellent radiological outcomes demonstrate that DCI is a safe and efficient treatment option in patients with degenerative cervical disorders.
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