OBJECT: The objective of the study was to generate prospective data to assess the clinical results after dynamic stabilization with the Cosmic system (Ulrich Medical). PATIENTS AND METHODS: Between April 2006 and December 2007, 103 consecutive patients were treated with Cosmic for painful degenerative segmental instability +/- spinal stenosis. The preoperative workup included radiological (MRI and myelography/CT) and clinical parameters (general/neurological examination, visual analogue scale (VAS), Oswestry disability index (ODI), SF-36, Karnofsky (KPS)). At pre-defined intervals (at discharge, 6 weeks, 3 months, 6 months, 12 months, and yearly) the patients were reevaluated (X-ray/flexion/extension, neurological status, VAS, ODI, SF-36, KPS, and patient satisfaction). Data were collected in a prospective observational design. RESULTS: Data collection was completed in 100 of 103 operated patients (mean follow-up, 15 +/- 0.6 months). Dynamic stabilization was performed as first-tier surgery in 43 cases and as second-tier therapy in 60 cases. Additional decompression was performed in 83 cases. Dynamic stabilization led to significant reduction of back pain-related disability (ODI pre-op, 51 +/- 1%; post-op, 21 +/- 1%) and improvement of pain (VAS pre-op, 65 +/- 1; post-op, 21 +/- 2), mental/physical health (norm-based SF-36: mental pre-op, 44; post-op, 48; physical pre-op, 41; post-op, 46), and mobility (KPS pre-op, 70 +/- 1; post-op, 82 +/- 31). Early reoperation was necessary in 12 patients (n = 3 symptomatic misplaced screws, n = 8 CSF pseudocele, rebleeding, or impaired wound healing, n = 1 misjudged instability/stenosis in adjacent segment). Reoperations within the follow-up period were necessary in another 10 patients due to secondary screw loosening (n = 2), persistent stenosis/disk protrusion in an instrumented segment (n = 3), symptomatic degeneration of an adjacent segment (n = 6), or osteoporotic fracture of an adjacent vertebra (n = 1), respectively. Patient satisfaction rate was 91%. CONCLUSIONS: Dynamic stabilization with Cosmic achieved significant improvement of pain, related disability, mental/physical health, and mobility, respectively, and a high rate of satisfied patients. A reoperation rate of 10% during follow-up seems relatively high at first glance. Comparable data, however, are scarce, and a prospective randomized trial (spondylodesis vs. dynamic stabilization) is warranted based on these results
Keywords : Adult,Aged,Aged,80 and over,Bone Screws,diagnostic imaging,etiology,Female,Germany,Humans,instrumentation,Lumbar Vertebrae,Magnetic Resonance Imaging,Male,methods,Middle Aged,Neurosurgery,Pain,pathology,Patient Satisfaction,Patients,physiopathology,Postoperative Complications,prevention & control,Prospective Studies,Recurrence,Reoperation,secondary,Spinal Diseases,Spinal Fusion,Spinal Stenosis,Spine,Spondylolysis,Spondylosis,standards,surgery,therapy,Thoracic Vertebrae,Tomography,X-Ray Computed,Treatment Outcome,Wound Healing,, Screwbased,Dynamic,Stabilization, ct scan spine cervical
Date of Publication : 2010 May
Authors : Stoffel M;Behr M;Reinke A;Stuer C;Ringel F;Meyer B;
Organisation : Department of Neurosurgery, Klinikum rechts der Isar, Technische Universitat Munchen, Ismaningerstrasse 22, Munich, Germany. michael.stoffel@lrz.tum.de
Journal of Publication : Acta Neurochir (Wien )
Pubmed Link : https://www.ncbi.nlm.nih.gov/pubmed/20084412
The London Spine Unit : Harley Street UK. Specialists in Cutting Edge Technologies for Spinal Surgery
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