The spine journal : official journal of the North American Spine Society
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Prospective randomized study of the Charite artificial disc: data from two investigational centers.
For decades there has been a desire to restore motion of a painful degenerated spinal segment. Artificial discs have been used in Europe for almost 20 years. In the few reports available in the literature, the results have been promising. However, there have been no prospective randomized studies comparing artificial discs with spinal fusion. ⋯ In this prospective randomized study, both surgical groups improved significantly. Complications of total disc replacement were similar to those encountered with anterior lumbar interbody fusion. Total disc replacement appears to be a viable alternative to fusion for the treatment of single-level symptomatic disc degeneration unresponsive to nonoperative management.
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Malignant spinal lesions may require surgical excision and segmental stabilization. The decision to perform a concomitant fusion procedure is influenced in part by the need for adjunctive chemotherapy as well as the patient's anticipated survival. Although some evidence exists that suggests that chemotherapy may inhibit bony healing, no information exists regarding the effect of chemotherapy on spinal fusion healing. ⋯ No significant differences in wound complications were noted with doxorubicin administration. A single dose of doxorubicin administered intravenously at the time of surgery appears to play a significant inhibitory role in the process of spinal fusion. If similar effects occur in humans, these data suggest that doxorubicin may be harmful to bone healing in a spine fusion if given during the perioperative period. Further investigation will be necessary to determine the effect of time to aid at determining whether doxorubicin administered several weeks pre- or postoperatively results in improved fusion rate, and whether bone morphogenetic proteins can overcome these inhibitory effects.
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Randomized Controlled Trial Comparative Study Clinical Trial
Lumbar spine arthroplasty using the ProDisc II.
The ProDisc was developed by Thierry Marnay, a French orthopedic surgeon, in the late 1980s. Marnay and his associate implanted ProDiscs into 64 patients from 1990 to 1993. Demonstrating remarkable intellectual restraint, he let this cohort of patients "incubate" so he could see their progress before performing any additional implantations. ⋯ Flexion and lateral bend range of motion was significantly improved in ProDisc patients compared with the fusion group (p= .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 to lumbar fusion for the surgical treatment of disabling mechanical low back pain secondary to lumbar disc disease.
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Multicenter Study Clinical Trial
The Lumbar I/F Cage for posterior lumbar interbody fusion with the variable screw placement system: 10-year results of a Food and Drug Administration clinical trial.
The Lumbar I/F Cage is a carbon fiber reinforced polymer (CFRP) device designed to separate the mechanical and device functions of interbody fusion. A Investigational Device Exemption (IDE) clinical study of the CFRP cage was conducted during an enrollment period from 1991 to 1993. Based on the 2-year results of this study, the cage was approved by the US Food and Drug Administration (FDA) in February 1999. Since then, the Lumbar I/F Cage device has become widely used in the United States. ⋯ The high rate of clinical success, fusion success, and patient satisfaction at 24 months was maintained at 10-year follow-up. Adjacent segment degeneration was common but was usually not clinically significant.
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Total disc arthroplasty serves as the next frontier in the surgical management of intervertebral discogenic pathology. ⋯ The implementation of dynamic spinal stabilization systems for fusionless correction of spinal deformity, dynamic posterior stabilization and total disc arthroplasty necessitates improved understanding with regard to spinal kinematics, patterns and mechanisms of histologic osseointegration and the neurohistopathologic response to particulate wear debris. Collectively, the current studies provide a methodologic basis to comprehensively evaluate these three areas.