• Michael Ahrens, Anthony Tsantrizos, Peter Donkersloot, Frederic Martens, Philippe Lauweryns, Jean Charles Le Huec, Slawomir Moszko, Zsolt Fekete, John Sherman, Hansen A Yuan, and Henry Halm.
• Clinic for Spine Surgery with Scoliosis Center, Klinikum Neustadt, Academic Teaching Hospital of University of Schleswig-Holstein, Campus Luebeck, Germany. Ahrens@orthocell.com
• Spine. 2009 Jun 1;34(13):1376-84.

Study DesignA prospective, nonrandomized multicenter study of lumbar disc nucleus replacement using the DASCOR Disc Arthroplasty Device. An interim analysis of clinical results is presented, obtained from European patients enrolled in 2 studies.ObjectiveTo determine the safety and efficacy of the DASCOR Device for the treatment of symptomatic single-level degenerative disc disease (DDD).Summary Of Background DataPatients suffering from DDD have been limited to a choice between nonoperative therapies or invasive surgical treatments such as total disc replacement or spinal fusion. The DASCOR Device was developed to provide an alternative treatment with a less invasive surgical intervention.MethodsA total of 85 patients from 11 European centers were enrolled in 1 of 2 studies between February 2003 and July 31, 2007. Data were collected before surgery and after surgery at 6 weeks and at 3, 6, 12, and 24 months. The clinical outcome measures were obtained from the Visual Analog Scale (VAS) for back pain, the Oswestry Disability Index (ODI), radiographic assessments, and records of analgesic medication use.ResultsMean VAS and ODI scores improved significantly after 6 weeks and throughout the 2 years. Radiographic results demonstrated, at a minimum, maintenance of disc height with no device expulsion and, despite Modic-Type 1 changes, no subsidence. Fourteen patients had serious adverse events including device explants in 7 patients (7 of 85), in which the main complication was resumed back pain after time. Patients' rate of analgesic medication decreased dramatically over time, with all patients experiencing significant improvements after 3 months and nearly no analgesic medication or narcotic drug use at 2 years.ConclusionThe interim outcomes showed significant improvements in mean ODI and VAS scores. The results of these European studies suggest that the DASCOR Device may be a safe and effective less-invasive surgical option for patients with DDD.

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