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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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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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
The effectiveness of extrication collars tested during the execution of spine-board transfer techniques.
In the prehospital stages of emergency care, cervical collars are (supposedly) used to aid rescuers in maintaining in-line stabilization of the spinal column as patients with potential or actual injuries are shifted onto a spine board to achieve full spinal immobilization. Unfortunately, not a single study has examined the effectiveness of cervical collars to control motion during the execution of spine-board transfer techniques. ⋯ The data presented here suggest that the collars tested in this study are functionally similar. It is recommended that this study be repeated with a larger sample size.