A New Zero-profile Implant for Stand-alone Anterior Cervical Interbody Fusion

Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik Frankfurt am Main, Friedberger Landstraße 430, 60389, Frankfurt am Main, Germany.
Clinical Orthopaedics and Related Research (Impact Factor: 2.77). 09/2010; 469(3):666-73. DOI: 10.1007/s11999-010-1597-9
Source: PubMed


Several studies suggest fusion rates are higher with anterior cervical discectomy and fusion procedures if supplemented with a plate. However, plates may be associated with higher postoperative morbidity and higher rates of dysphagia. This led to the development of a cervical stand-alone cage with integrated fixation for zero-profile segmental stabilization.
We asked whether this new implant would be associated with a low rate of dysphagia and other short-term complications in patients having anterior cervical discectomy and fusion and would be able to achieve solid fusion and maintain postoperative reduction in pain.
We prospectively followed 38 patients with radiculopathy/myelopathy undergoing anterior cervical discectomy and fusion using the new implant. Intraoperative parameters, clinical features (Neck Pain Disability Index, visual analog scale score for neck/arm pain, Odom's criteria), and dysphagia scores were recorded. Radiographs were taken to assess implant failure. Thirty-four patients had a minimum 6 months' followup (mean, 8 months; range, 6-11 months).
Three patients at 6 weeks and one patient at 6 months complained about minor dysphagia-related symptoms. There was no hardware failure recordable and all patients had evidence of fusion. Compared to preoperatively, visual analog scale pain score and Neck Pain Disability Index were reduced at 6 weeks' followup without change during further followup.
The new cervical stand-alone anterior fusion device allows decompression and fusion with low complication rates. The incidence of chronic postoperative dysphagia was infrequent in comparison to published data. Prospective randomized trials with more patients and longer followup are necessary to confirm these observations.
Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

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Available from: Matti Scholz, Mar 05, 2014
    • "We had very low incidence of early postoperative dysphagia (13%) with 0% incidence of dysphgia at 3 months. Similarly, Scholz et al.[19] used a zero-profile device and reported a low incidence of dysphagia (3%) at 3-month follow-up. They however had very high incidence of early dysphagia (62%) in contrast to that in our study. "
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    ABSTRACT: To analyze the clinical and radiographic results following the use of integrated intervertebral implant in patients with cervical spine degenerative disease. Though excellent results have been reported following anterior cervical discectomy and fusion using iliac crest autograft/allograft with plating, the morbidity associated with autograft harvest and small chances of complications with plating always exists. Recently, there has been development of a cervical stand-alone cage with integrated fixation for cervical fusion and stabilization with a possible low morbidity and optimal clinical outcome. A retrospective study of 16 patients who underwent anterior cervical discectomy and fusion using the integrated intervertebral device was performed. Intra-operative parameters, clinical features [Neck Disability Index (NDI), visual analog scale (VAS) score for neck/arm pain], and presence or absence of dysphagia was recorded. Radiographs were evaluated for assessment of implant failure and fusion. Mean age of patients was 54 years (range: 38-84 years) with male: female ratio of 1:3. Follow-up ranged from 6 to 12 months (mean: 10 months). In the early postoperative period, 2 of the 15 patients (13%) patients had mild dysphagia that resolved during follow-up with no patient having complaints of dysphagia at 3-month follow-up. One of the patients with diffuse idiopathic skeletal hyperostosis (DISH) and severe preoperative dysphagia had significant improvement in swallowing function at 3-month follow-up that was stable at 1-year follow-up. There was no evidence of implant failure, with fusion occurring in 95% (19/20) of operated levels. Analysis of follow-up VAS and NDI scores showed significant reduction in VAS score for neck pain (P < 0.019), radicular arm pain (P < 0.003), and NDI score (P < 0.007) in 77, 92, and 77% of patients, respectively, at a mean follow-up of 10 months (6-12 months). Our preliminary results with the use of this cervical stand-alone anterior fusion device with integrated screw fixation show its efficacy in anterior cervical decompression and fusion with stabilization with optimal clinical and radiographic outcome. Lower chances of dysphagia with no device-related complications are appealing, which needs to be verified in larger studies.
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    ABSTRACT: Degenerative cervical spine disorders will affect up to two-thirds of the population in their lifetime. While often benign and episodic in nature, cervical disorders may become debilitating resulting in severe pain and possibly neurologic sequelae. Non-operative treatment continues to play an important role in treating these patients, with medications, therapy and interventional pain injections playing increasing roles in treatment. Surgical treatment including anterior and posterior decompression and fusion have been effective treatments of many cervical disorders, but may lead to significant problems including adjacent level disease. Laminotomy/foraminotomy and total disc arthroplasty may avoid some of these problems while providing similar clinical results. Ongoing clinical trials and studies are helping to define the role of these new technologies in treatment of patients with degenerative cervical disorders, although their greater benefit has yet to be proven.
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    ABSTRACT: A prospective study. The aim of this study was to compare the 3 different methods of interbody fusion of the cervical spine-autograft in stand-alone technique, autograft with anterior plate, and polyetheretherketone cage supported by anterior plate. The clinical and radiological data obtained were analyzed and discussed. Although degenerative cervical spine disease has been treated by an anterior approach for more than 50 years, there is not one generally accepted operative approach. There is a very low-quality evidence of little or no difference in pain relief between each of the techniques. Iliac crest autograft still seems to be the "gold standard" for interbody fusion. Prospective study collecting clinical and radiological data of 81 patients undergoing anterior cervical interbody fusion, in which the interbody fusion of 1 or 2 motion segments from C3 to C7 was done by any of the 3 techniques--stand-alone insertion of autograft (group 1: 28 patients), autograft and anterior plate (group 2: 18 patients), and polyetheretherketone cage filled with beta-tricalcium phosphate and plate (group 3: 29 patients). Patients were followed for 2 years after surgery. Significant interaction of relative height in the segment and time was found (P < 0.001). The values of the relative height of stand-alone autograft dropped below 95% of initial height and the values of the other 2 groups remained above 105%. Significant interaction of time and group was found for Cobb S angles (P < 0.001). Values of group 1 decreased substantially and remained significantly lower than values of other 2 groups. Fusion rate was 100% in all groups. Neck Disability Index group and time interaction was found (P = 0.023). During postoperative follow-up, group 1 scored in all controls higher than the other 2 groups, but differences were not significant. Visual analogue scale showed effect of time (P < 0.001). This was due to a smaller improvement of patients in group 1 during the whole follow-up in comparison with the other 2 groups. Highest proportion of unsatisfied patients was in group 1 compared with the other 2 groups after 2 years (P = 0.034). Significantly worse radiological and clinical results after 2 years of follow-up were achieved using stand-alone autograft technique in comparison with autograft supported by anterior plating similarly as in comparison with cage implant and anterior plating. Using artificial fusion substrate together with plate and cage can offer the same clinical and radiological results such as iliac autograft and plating. Anterior plating seems to be an important factor influencing the postoperative cervical spine alignment and also the clinical outcome.
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