Christoph Mehren1,2, Franziska Heider3,4, Christoph J Siepe3,4, Bernhard Zillner3,4, Ralph Kothe5,6, Andreas Korge3,4, H Michael Mayer3,4. 1. Schön Klinik München Harlaching, Spine Center, Harlachinger Strasse 51, 81547, Munich, Germany. cmehren@schoen-kliniken.de. 2. Academic Teaching Hospital and Spine Research Institute, Paracelsus Private Medical University Salzburg, Salzburg, Austria. cmehren@schoen-kliniken.de. 3. Schön Klinik München Harlaching, Spine Center, Harlachinger Strasse 51, 81547, Munich, Germany. 4. Academic Teaching Hospital and Spine Research Institute, Paracelsus Private Medical University Salzburg, Salzburg, Austria. 5. Schön Klinik Eilbeck, Clinic for Spinal Surgery, Hamburg, Germany. 6. Department of Orthopedics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Abstract
PURPOSE: Previous studies have demonstrated that total cervical disc replacement (cTDR) represents a viable treatment alternative to the 'gold standard' anterior cervical discectomy and fusion for the treatment of well-defined cervical pathologies at short- and mid-term follow-up (FU). However, the implementation and acceptance of a non-fusion philosophy is closely associated with its avoidance of adjacent segment degeneration. Proof of the functional sustainability and clinical improvement of symptoms at long-term FU is still pending. The aim of this ongoing prospective study was to investigate the clinical and radiological results of cTDR at long-term FU. METHODS: 50 patients were treated surgically within a non-randomised prospective study framework with cTDR (ProDisc C™, Synthes, Paoli, PA, USA). Patients were examined preoperatively followed by routine clinical and radiological examinations at 1, 5 and 10 years after surgery, respectively. In addition to the clinical scores, conventional X-ray images of the cervical spine were taken in anteroposterior and lateral view as well as flexion/extension images. Clinical outcome scores included parameters such as the Neck Disability Index (NDI), Visual Analogue Scale (VAS), arm and neck pain self-assessment questionnaires as well as subjective patient satisfaction rates. The radiological outcome variables included the range of motion (ROM) of the implanted prosthesis between maximum flexion and extension images, the occurrence of heterotopic ossifications and radiographic signs of adjacent segment degenerative changes. The reoperation rate following cTDR was recorded as a secondary outcome variable. RESULTS: A significant and maintained clinical improvement of all clinical outcome scores was observed after a mean FU of 10.2 years (VASarm 6.3-2.1; VASneck 6.4-1.9; NDI 21-6; p < 0.05). An increase in the incidence and the extent of heterotopic ossifications was noted during the post-operative course with a significant influence on the function of the prosthesis, which, however, did not reveal any detrimental effect on the patients' clinical symptomatology. Prosthesis mobility declined from 9.0° preoperatively and 9.1° at 1 year FU to 7.7° and 7.6° at the five- and ten-year FU examinations, respectively. Radiological signs of adjacent segment degeneration were detected in 13/38 (35.7%), however, in only 3/38 (7.9%) patients this radiological changes were associated with clinical symptoms requiring conservative treatment. Intraoperative technical failure in two cases required interbody fusion with a cage (2/50). One patient (1/48, 2.1%) treated this motion device had revision surgery at the index level. CONCLUSION: Cervical total disc replacement with ProDisc C demonstrated a significant and maintained improvement of all clinical outcome parameters at a follow-up of ≥10 years. The present long-term data reveal that with an exceptionally low implant-related reoperation rate and low symptomatic adjacent segment degeneration rate, cTDR may be regarded as a safe and viable treatment option.
PURPOSE: Previous studies have demonstrated that total cervical disc replacement (cTDR) represents a viable treatment alternative to the 'gold standard' anterior cervical discectomy and fusion for the treatment of well-defined cervical pathologies at short- and mid-term follow-up (FU). However, the implementation and acceptance of a non-fusion philosophy is closely associated with its avoidance of adjacent segment degeneration. Proof of the functional sustainability and clinical improvement of symptoms at long-term FU is still pending. The aim of this ongoing prospective study was to investigate the clinical and radiological results of cTDR at long-term FU. METHODS: 50 patients were treated surgically within a non-randomised prospective study framework with cTDR (ProDisc C™, Synthes, Paoli, PA, USA). Patients were examined preoperatively followed by routine clinical and radiological examinations at 1, 5 and 10 years after surgery, respectively. In addition to the clinical scores, conventional X-ray images of the cervical spine were taken in anteroposterior and lateral view as well as flexion/extension images. Clinical outcome scores included parameters such as the Neck Disability Index (NDI), Visual Analogue Scale (VAS), arm and neck pain self-assessment questionnaires as well as subjective patient satisfaction rates. The radiological outcome variables included the range of motion (ROM) of the implanted prosthesis between maximum flexion and extension images, the occurrence of heterotopic ossifications and radiographic signs of adjacent segment degenerative changes. The reoperation rate following cTDR was recorded as a secondary outcome variable. RESULTS: A significant and maintained clinical improvement of all clinical outcome scores was observed after a mean FU of 10.2 years (VASarm 6.3-2.1; VASneck 6.4-1.9; NDI 21-6; p < 0.05). An increase in the incidence and the extent of heterotopic ossifications was noted during the post-operative course with a significant influence on the function of the prosthesis, which, however, did not reveal any detrimental effect on the patients' clinical symptomatology. Prosthesis mobility declined from 9.0° preoperatively and 9.1° at 1 year FU to 7.7° and 7.6° at the five- and ten-year FU examinations, respectively. Radiological signs of adjacent segment degeneration were detected in 13/38 (35.7%), however, in only 3/38 (7.9%) patients this radiological changes were associated with clinical symptoms requiring conservative treatment. Intraoperative technical failure in two cases required interbody fusion with a cage (2/50). One patient (1/48, 2.1%) treated this motion device had revision surgery at the index level. CONCLUSION: Cervical total disc replacement with ProDisc C demonstrated a significant and maintained improvement of all clinical outcome parameters at a follow-up of ≥10 years. The present long-term data reveal that with an exceptionally low implant-related reoperation rate and low symptomatic adjacent segment degeneration rate, cTDR may be regarded as a safe and viable treatment option.
Authors: Reginald J Davis; Kee D Kim; Michael S Hisey; Gregory A Hoffman; Hyun W Bae; Steven E Gaede; Ralph F Rashbaum; Pierce Dalton Nunley; Daniel L Peterson; John K Stokes Journal: J Neurosurg Spine Date: 2013-09-06
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