Jan Stulik1, Marton Ronai2, Bruno Rudinsky3, Daniel Zarzycki4, Dariusz Latka5, Jiri Matejka6, Saleh Baeesa7. 1. Department of Spondylosurgery, University Clinic Motol, Praha, Czech Republic. 2. Department of Orthopaedics, National Center for Spinal Disorders, Budapest, Hungary. 3. Department of Neurosurgery, Faculty Hospital Nové Zámky, Slovakia. 4. Department of Orthopaedic and Rehabilitation, Jagiellonian Uniniversity Hospital, Zakopane, Poland. 5. Department of Neurosurgery, Opole University, Institute of Medicine, University Hospital, Poland. 6. Department of Orthopaedics and Traumatology of the Locomotor System of the Medical Faculty and the University Hospital in Pilsen, Plzen, Czech Republic. 7. Division of Neurosurgery, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
Abstract
BACKGROUND: To describe routine surgical practice using Prestige LP Cervical Disc (Prestige disc) and patient outcomes for degenerative cervical disc disease in a multicenter 2-year prospective, observational study. METHODS: Patient demographics and intraoperative data were collected; quality of life (QoL) (EQ-5D, EQ-VAS, and neck disability index), average disc height, and adverse events were assessed pre- and postoperatively at 3, 6, 12, and 24 months. RESULTS: One hundred and ninety-four patients were enrolled (190 patients implanted; female: 67%; mean age: 44.0 years; mean body mass index: 25.6). Disc herniation was the most frequent indication for cervical arthroplasty (80.5%). Thirty-seven percent of patients experienced pain for >1 year prior to baseline assessment. Mean procedure duration was 87.1 minutes, and mean blood loss was 43.8 mL. The majority (71.0%) of Prestige discs were implanted at level C5 to C6, while 16.3% of patients received implants at 2 levels. There was a significant improvement from baseline to 3, 6, 12, and 24 months of follow-up in all QoL assessments. After implantation, the mean disc height at the affected level increased by 0.19 from baseline (0.22) to 3 months (0.41) and remained constant up to 24 months (P < .001). Mean disc height of levels above and below the implant remained comparable at baseline and follow-up. A total of 63 adverse events (44 patients) was recorded, of which 7 (11.1%) were related to the Prestige disc, instrumentation, or procedure; 41 (65.1%) were unrelated; and 15 (23.8%) had an unknown relation. CONCLUSIONS: In line with published findings, our study shows significant improvement in outcomes in the first 3 months after Prestige disc implantation with improvements maintained throughout the study.
BACKGROUND: To describe routine surgical practice using Prestige LP Cervical Disc (Prestige disc) and patient outcomes for degenerative cervical disc disease in a multicenter 2-year prospective, observational study. METHODS: Patient demographics and intraoperative data were collected; quality of life (QoL) (EQ-5D, EQ-VAS, and neck disability index), average disc height, and adverse events were assessed pre- and postoperatively at 3, 6, 12, and 24 months. RESULTS: One hundred and ninety-four patients were enrolled (190 patients implanted; female: 67%; mean age: 44.0 years; mean body mass index: 25.6). Disc herniation was the most frequent indication for cervical arthroplasty (80.5%). Thirty-seven percent of patients experienced pain for >1 year prior to baseline assessment. Mean procedure duration was 87.1 minutes, and mean blood loss was 43.8 mL. The majority (71.0%) of Prestige discs were implanted at level C5 to C6, while 16.3% of patients received implants at 2 levels. There was a significant improvement from baseline to 3, 6, 12, and 24 months of follow-up in all QoL assessments. After implantation, the mean disc height at the affected level increased by 0.19 from baseline (0.22) to 3 months (0.41) and remained constant up to 24 months (P < .001). Mean disc height of levels above and below the implant remained comparable at baseline and follow-up. A total of 63 adverse events (44 patients) was recorded, of which 7 (11.1%) were related to the Prestige disc, instrumentation, or procedure; 41 (65.1%) were unrelated; and 15 (23.8%) had an unknown relation. CONCLUSIONS: In line with published findings, our study shows significant improvement in outcomes in the first 3 months after Prestige disc implantation with improvements maintained throughout the study.
Entities:
Keywords:
cervical spine; Prestige LP Cervical Disc; arthroplasty; degenerative disc disease; quality of life
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