The spine journal : official journal of the North American Spine Society
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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.
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Comparative Study
Comparison of clinical and radiographic outcome in instrumented anterior cervical discectomy and fusion with or without direct uncovertebral joint decompression.
Anterior cervical discectomy and fusion (ACDF) is an established procedure for the operative treatment of cervical disc disease in patients with radiculopathy resulting from impingement from uncovertebral joint osteophytes. Studies demonstrate that direct decompression of the lesion provides good result. However, known complications include vertebral artery injury, dural tears, nerve root injury, loss of biomechanical stability and increased operative time. Other studies suggest that disc space distraction may play an important role by indirectly decompressing neural elements. Therefore, if equivalent functional outcomes can be achieved without sacrificing the uncovertebral joint, then potential morbidity and mortality could be decreased. ⋯ Good to excellent results were obtained in 84.5% and 84.2% of patients for Groups 1 and 2, respectively. Indirect foraminal decompression through distraction remains somewhat controversial during ACDF. However, sacrificing the uncovertebral joint can increase operative time and potentially increase complication rates. This study demonstrates that ACDF with or without direct uncovertebral joint decompression can provide good clinical results for neck pain with cervical radiculopathy. Therefore, routine direct uncovertebral joint decompression should not be undertaken during ACDF.
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Comparative Study
In vitro measurement of pressure in intervertebral discs and annulus fibrosus with and without annular tears during discography.
Discogram studies have shown that pain reproduction correlates with the extent of annular disruption. However, it has not been assessed if pressure changes in the annulus fibrosus vary incrementally with intradiscal pressure. ⋯ Volumetric injection of intervertebral discs with a torn annulus fibrosis during discography may increase intra-annular pressure similar to the increase in pressure that may occur during spinal loading activities. This effect may not occur in discs with an intact annulus fibrosus.