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ProDisc-C versus fusion with Cervios chronOS prosthesis in cervical degenerative disc disease: Is there a difference at 12 months?

ABSTRACT: STUDY DESIGN: Prospective cohort study. OBJECTIVE: The aim of the study was to compare clinical results and to determine differences in outcomes between anterior cervical discectomy and fusion (ACDF) and disc arthroplasty in patients treated for symptomatic cervical degenerative disc disease. METHODS: Forty patients with cervical degenerative disc disease were treated with ProDisc-C disc arthroplasty and 40 patients with fusion using an intervetebral spacer with integrated fixation (Cervios chronoOS) implants without additional anterior fixation. Fifty disc prostheses were placed in the first group and 52 intervertebral spacers were implanted in the second group. Clinical outcomes were assessed before and 12 months following the procedure using the neck disability index (NDI) and visual analog scale (VAS) for neck and arm pain, with 15% improvement in NDI and 20% in VAS defined as a clinically significant. RESULTS: Eighty patients with cervical degenerative disc disease with a mean age of 49.7 years were included in the study with a minimum follow-up of 12 months. The groups were similar at baseline both clinically and statistically (P > .05) except for age and VAS for arm pain. Both groups had a statistically significant improvement in NDI and VAS for neck and arm pain (P < .05) and the arthroplasty group had a better improvement according to NDI (74.3% of patients in the arthroplasty group achieved ≥15% improvement in NDI versus 65.7% of patients in ACDF group). CONCLUSIONS: Both ProDisc C and Cervios chronoOS prostheses resulted in significant pain reduction and functional outcome for the patients with slightly better results in the group treated with disc arthroplasty 12 months after the surgery. [Table: see text] The definiton of the different classes of evidence is available on page 83.

SUBMITTER: Vorsic M

PROVIDER: S-EPMC3609006 | biostudies-other | 2010 May

REPOSITORIES: biostudies-other

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Project description:BackgroundAdult spinal deformity, especially sagittal imbalance, is affecting health-related quality-of-life (HRQOL) scores. There is a lack of emphasis in the comparison of cervical sagittal parameters in patients with degenerative cervical spondylolisthesis and degenerative cervical kyphosis. The aim of study is to determine the preoperative and postoperative cervical sagittal parameters in myeloradiculopathic patients with degenerative cervical spondylolisthesis and degenerative cervical kyphosis treated by anterior cervical discectomy and fusion (ACDF).MethodsA retrospective medical records and radiographic study of 30 adult patients were reviewed. Fifteen patients with degenerative cervical spondylolisthesis and 15 patients with degenerative cervical kyphosis have been performed ACDF from 2010-2020. We measured the preoperative and postoperative cervical sagittal parameters: C0-C2 angle, C1-C2 angle, C2-C7 angle, C2-C7 sagittal vertical axis (SVA), T1 slope, neck tilt angle and thoracic inlet angle. Minimum follow-up period was at least 2 years.ResultsPatients in degenerative cervical kyphosis group have C2-C7 angle less than degenerative cervical spondylolisthesis group (-14.88±7.32 vs. 9.60±13.60), leading to increase the mismatch between T1 slope and C2-C7 angle in kyphotic group and hyperlordosis of C0-C2 angle and C1-C2 angle (31.13±7.68, 37.88±5.08) compare with spondylolisthesis group (13±10.20, 24.60±10.70). Whereas patients with degenerative cervical spondylolisthesis have C2-C7 SVA (33.22±13.92) more than kyphosis group (13.70±13.60). After surgery, there is significant increase of the C2-C7 angle in the kyphosis group compare before and after surgery (-14.88±7.32 vs. 4.10±11.80). While the spondylolisthesis group has no significantly different parameters compare to before surgery. However, the postoperative cervical sagittal parameters of all patients are within the normal thresholds (T1-Slope minus C2-C7 lordosis <15° and C2-C7 SVA <40 mm).ConclusionsThe study demonstrates the difference of sagittal parameters between degenerative cervical spondylolisthesis and kyphosis before and after surgery. ACDF not only provides neural decompressive procedure, but also corrects the regional cervical sagittal parameters.

Project description:BackgroundCervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical pathologies. Studies are on-going to assess the long term outcomes of CDA. This study assessed the safety and efficacy of the Prestige(®) LP Disc at 84-months follow up.MethodsProspective data from 280 CDA patients with single-level cervical disc disease with radiculopathy or myelopathy were compared with 265 historical control ACDF patients. Clinical and radiographic follow up was completed pre-operatively, intraoperatively, and at intervals up to 84 months.ResultsFollow-up rate was 75.9% for CDA and 70.0% for ACDF patients. Statistical improvements (p < 0.001) in Neck Disability Index (NDI), neck/arm pain, and SF-36 were achieved by 1.5 months in both groups and maintained through 84 months. At 84 months, 86.1% of CDA versus 80.1% of ACDF patients achieved NDI success, (≥15-point improvement over baseline). Mean NDI score improvements exceeded 30 points in both groups. SF-36 PCS/MCS mean improvements were 13.1±11.9/8.2±12.3 points for CDA and 10.7±11.8/8.3±13.6 points for ACDF. Neurological success was 92.8% for CDA and 79.7% for ACDF patients. The rate of Overall Success was 74.9% for CDA and 63.2% for ACDF. At 84 months, 17.5% of CDA and 16.6% of ACDF patients had a possibly implant- or implant-surgical procedure-related adverse event. Eighteen (6.4%) CDA and 29 (10.9%) ACDF patients had a second surgery at the index level. In CDA patients, mean angular motion at the target level was maintained at 24 (7.5°) and 84 (6.9°) months. Bridging bone was reported in 5.9%/9.5%/10.2%/13.0% of CDA patients at 24/36/60/84 months. Change in mean preoperative angulation of the adjacent segment above/below the index level was1.06±4.39/1.25±4.06 for CDA and (-0.23)±5.37/1.25±5.07 for ACDF patients. At 84 months, 90.9% of CDA and 85.6% of ACDF patients were satisfied with the results of their treatment.ConclusionsPrestige LP maintained significantly improved clinical outcomes and segmental motion; statistical superiority of CDA was concluded for overall success. This investigational device exemption study was sponsored by Medtronic Spinal and Biologics, Memphis, TN. Study approved by the Hughston Sports Medicine Center Institutional Review Board on January 7, 2005. Clinical trial registered at clinicaltrials.gov: NCT00667459. All participants signed an informed consent.

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ProDisc-C versus fusion with Cervios chronOS prosthesis in cervical degenerative disc disease: Is there a difference at 12 months?

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