Dynamic cervical stabilization: a multicenter study.

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.

Stabilization with the Dynamic Cervical Implant: a novel treatment approach following cervical discectomy and decompression.

OBJECT: Although cervical total disc replacement (TDR) has shown equivalence or superiority to anterior cervical discectomy and fusion (ACDF), potential problems include nonphysiological motion (hypermobility), accelerated degeneration of the facet joints, particulate wear, and compromise of the mechanical integrity of the endplate during device fixation. Dynamic cervical stabilization is a novel motion-preserving concept that facilitates controlled, limited flexion and extension, but prevents axial rotation and lateral bending, thereby reducing motion across the facet joints. Shock absorption of the Dynamic Cervical Implant (DCI) device is intended to protect adjacent levels from accelerated degeneration. METHODS: The authors conducted a prospective evaluation of 53 consecutive patients who underwent DCI stabilization for the treatment of 1-level (n = 42), 2-level (n = 9), and 3-level (n = 2) cervical disc disease with radiculopathy or myelopathy. Forty-seven patients (89%) completed all clinical and radiographic outcomes at a minimum of 24 months. Clinical outcomes consisted of Neck Disability Index (NDI) and visual analog scale (VAS) scores, neurological function at baseline and at latest follow-up, as well as patient satisfaction. Flexion-extension radiography was evaluated for device motion, implant migration, subsidence, and heterotopic ossification. Cervical sagittal alignment (Cobb angle), functional spinal unit (FSU) angle, and range of motion (ROM) at index and adjacent levels were evaluated with WEB 1000 software. RESULTS: The NDI score, VAS neck and arm pain scores, and neurological deficits were significantly reduced at each postoperative time point compared with baseline (p < 0.0001). At 24 months postoperatively, 91% of patients were very satisfied and 9% somewhat satisfied, while 89% would definitely and 11% would probably elect to have the same surgery again. In 47 patients with 58 operated levels, the radiographic assessment showed good motion (5°-12°) of the device in 57%, reduced motion (2°-5°) in 34.5%, and little motion (0-2°) in 8.5%. The Cobb and FSU angles improved, showing a clear tendency for lordosis with the DCI. Motion greater than 2° of the treated segment could be preserved in 91.5%, while 8.5% had a near segmental fusion. Mean ROM at index levels demonstrated satisfying motion preservation with DCI. Mean ROM at upper and lower adjacent levels showed maintenance of adjacent-level kinematics. Heterotopic ossification, including 20% minor and 15% major, had no direct impact on clinical results. There were 2 endplate subsidences detected with an increased segmental lordosis. One asymptomatic anterior device migration required reoperation. Three patients underwent a secondary surgery in another segment during follow-up, twice for a new disc herniation and once for an adjacent degeneration. There was no posterior migration and no device breakage. CONCLUSIONS: Preliminary results indicate that the DCI implanted using a proper surgical technique is safe and facilitates excellent clinical outcomes, maintains index-and adjacent-level ROM in the majority of cases, improves sagittal alignment, and may be suitable for patients with facet arthrosis who would otherwise not be candidates for cervical TDR. Shock absorption together with maintained motion in the DCI may protect adjacent levels from early degeneration in longer follow-up.