Journal of spinal disorders & techniques
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J Spinal Disord Tech · Aug 2003
Case ReportsComplications of artificial disc replacement: a report of 27 patients with the SB Charité disc.
Disc prosthesis surgery is rapidly becoming an option in treating patients with symptomatic degenerative disc disease. Only short-term and midterm results are described in the literature. Most operated patients belong to the age group of 30-50 years. ⋯ These procedures resulted in suboptimal long-term results. In this relatively small group of patients operated on with a Charité disc prosthesis, most problems arose from degeneration of other lumbar discs, facet joint arthrosis at the same or other levels, and subsidence of the prosthesis. It is to be expected that many more patients will be seen with late problems some years after this operation as the survivorship will decrease with time.
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J Spinal Disord Tech · Aug 2003
Randomized Controlled Trial Comparative Study Clinical TrialLumbar spine arthroplasty: early results using the ProDisc II: a prospective randomized trial of arthroplasty versus fusion.
This study represents the first 39 patients with at least 6-month follow-up enrolled in a prospective randomized Food and Drug Administration study evaluating the safety and efficacy of the ProDisc II versus the control, a 360 degrees lumbar spinal fusion. Data were collected preoperatively and at 6 weeks, 3 months, and 6 months postoperatively. Visual Analog Scale (VAS), Oswestry Low Back Pain Disability Questionnaire (ODQ), and patient satisfaction rates were evaluated at these intervals, as well as range of motion, return to work, and recreational and ambulatory status. ⋯ A trend was identified at 6 months in patient satisfaction rates favoring ProDisc versus fusion (P = 0.08), and motion was significantly improved in ProDisc patients compared with the fusion group (P = 0.02). Ambulatory status as well as recreational activity improved faster in the ProDisc group. The data suggest that total disc arthroplasty may be an attractive option as opposed to lumbar fusion for the surgical treatment of disabling mechanical low back pain secondary to lumbar disc disease.
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J Spinal Disord Tech · Aug 2003
Comparative Study Clinical TrialLumbar disc replacement: preliminary results with ProDisc II after a minimum follow-up period of 1 year.
Total disc replacement has the potential to replace fusion as the gold standard surgical treatment of degenerative disc disease. Potential advantages of disc replacement over fusion include avoidance of pseudarthrosis, postoperative orthoses, and junctional degeneration. After observing satisfactory clinical results at 7-11 years' follow-up with the ProDisc first-generation implant, a second-generation prosthesis was designed. ⋯ Three patients (6%) required reoperation to address complications. No mechanical failure of the implants or loosening was observed, and the prostheses retained motion. Randomized, prospective, long-term studies will be necessary to compare the effectiveness of arthrodesis with total disc replacement.