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Intervertebral Disc Prostheses

These improvements were maintained at month follow-up examination. Patients in whom bone mineral density was decreased underwent same-session vertebroplasty Alloy CPB implantation of the ProDisc device s.

There were Alloy CPB cases involving neurological deterioration: Both deficits occurred in patients in whom there was evidence pre-operatively of circumferential spinal stenosis. There were 2 cases of implant subsidence and no thrombo-embolic phenomena. These researchers concluded that significant improvements in patient satisfaction and ODI scores were observed by 3 months post-operatively and these improvements were maintained at the 2-year follow-up examination. Although the authors' early results indicate that the use of ProDisc lumbar total disc arthroplasty in patients older than 60 years of age reduces chronic LBP and improves clinical functional outcomes, they recommend the judicious use of artificial disc replacement in this age group. Until further findings are reported, the authors Alloy CPB recommend the use of artificial disc replacement in the treatment of chronic discogenic LBP in patients older than age 60 years in whom bone quality is adequate in the absence of circumferential spinal stenosis.

Bertagnoli and associates c reported that lumbar total disc arthroplasty utilizing the ProDisc prosthesis is equally effective in smokers and non-smokers.


These investigators performed a prospective analysis on patients with disabling discogenic LBP treated with single-level lumbar Alloy CPB total disc arthroplasty. Smokers and non-smokers were evaluated before surgery and after Alloy CPB using patient satisfaction, Oswestry, and VAS.

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Additionally, pre-operative and post-operative neurological, radiographical, and pain medication assessments were performed at similar post-operative intervals. Oswestry, VAS, and patient satisfaction scores revealed statistical improvement beginning 3 months after surgery and were maintained at minimum 2-year follow-up. Alloy CPB

No cases of loosening, dislodgment, mechanical failure, infection, or fusion of the Alloy CPB segment occurred. The authors concluded that the findings of this study indicate that smokers do equally well as non-smokers when ProDisc artificial disc replacement is used in the treatment of debilitating lumbar spondylosis. Patient outcome and radiographical scores showed significant Alloy CPB compared with pre-operative levels. Hannibal et al examined if there is a clinical difference between the 1-level ProDisc patients versus the 2-level ProDisc patients at a minimum of 2-year follow-up.


Patients were part of the FDA clinical trial for the Prodisc II versus circumferential fusion study at a single institution. These investigators identified 27 patients who received ProDisc at 1 level and 32 who received it at 2 levels with at least a 2-year follow-up, for a total of 59 patients. While patients receiving ProDisc at 2 levels scored marginally lower in all evaluation indexes, score differences in each category were also found Alloy CPB hold no statistical significance. The authors concluded that this study was unable to identify a statistically significant difference in outcome between 1- and 2-level ProDisc arthroplasty patients in a cohort from a single center.

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Alloy CPB They stated that the equality of clinical effectiveness between 1- and 2-level ProDisc has yet to be determined. CMS announced that Section For Medicare beneficiaries 60 years of age and under, there is no national coverage determination, leaving such determinations to be made on a local basis. An interventional procedure consultation document prepared for the National Institute for Health and Clinical Excellence NICE, included the following provisional recommendations: A multi-disciplinary team with specialist expertise in the treatment of degenerative spine disease should be involved in patient selection for prosthetic intervertebral disc replacement in the lumbar spine. The procedure should only be carried out in patients for whom conservative treatment options have failed or are contraindicated.

The current evidence is based on studies with maximum follow-up of 13 years. NICE encourages clinicians to continue to collect and publish data on Alloy CPB outcomes, which should include information about patient selection and the need for further surgery. This report summarized the clinical findings after 5 years of follow-up.

A total of patients were treated and followed-up for 5 years; TDRs and 75 fusions had been Alloy CPB in these patients. The primary outcome was a component success end-point. Secondary outcome measures included neurological status, secondary surgery, ODI, SF, VAS assessing pain and satisfaction, radiographic data, narcotic use, activity, and recreation status. Patients were monitored through their 5-year post-operative visits under the FDA post-market surveillance provisions in the original investigational device exemption approval.


The overall follow-up rate at 5 years was Study success demonstrated that TDR was non-inferior to fusion with a Alloy CPB, none of the TDRs developed spontaneous fusion. The authors concluded that patients in both groups maintained significant improvement during the 5-year follow-up. Alloy CPB

The TDR group had significantly better improvement on some scales. Although TDR patients avoid the stiffness of fusion and are more satisfied than fusion patients, both fusion and TDR are reasonable surgical options in this specific patient population. Zigler and colleagues reported report the 5-year results for radiographically demonstrated adjacent-level degenerative changes from a prospective multi-center study in which patients were randomized to either TDR or circumferential fusion for single-level lumbar DDD. A total of patients with single-level lumbar DDD were enrolled and randomly assigned Alloy CPB 2 treatment groups: Radiographic Alloy CPB data 5 years after treatment were available for TDR patients and 43 fusion patients.

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To characterize adjacent-level degeneration ALDradiologists at an independent facility read the radiographic films. Adjacent-level degeneration was characterized by a composite score including disc height loss, endplate sclerosis, osteophytes, and spondylolisthesis. Alloy CPB in ALD at 5 years were observed in 9. Among the patients without adjacent-level disease pre-operatively, new findings of ALD at 5 years post-treatment were apparent in only 6. Alloy Name, Color, Type, ADA Classification, Co (%), Ni (%), Cr (%), Be (%). Alloy CPB CC · Argeloy Partial Grain, White, 5, Cobalt base (cpb), 64, 0, 28, 0.


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