✓ After the successful isolation of human embryonic stem cells in 1998, ethics and policy debates centered on the moral status of the embryo—whether the 2- to 4-day-old blastocyst is a person, and whether we should protect it at all costs. As the research has moved quickly forward, however, new questions have emerged for the study of stem cell ethics, law, and policy. Powerful new lines made without eggs or embryos have recently been reported, the intellectual property and regulatory environment is uncertain, and clinical trials using adult stem cells and cells derived from embryonic stem cells are about to commence. The new landscape of ethics, law, and policy is discussed in the context of these developments, with an emphasis on the evaluation of risks and benefits for first-in-human clinical studies.
Christopher Thomas Scott
Charles G. diPierro, Gregory A. Helm, Christopher I. Shaffrey, James B. Chadduck, Scott L. Henson, Jacek M. Malik, Thomas A. Szabo, Nathan E. Simmons and John A. Jane
✓ A new surgical technique for the treatment of lumbar spinal stenosis features extensive unilateral decompression with undercutting of the spinous process and, to preserve stability, uses contralateral autologous bone fusion of the spinous processes, laminae, and facets. The operation was performed in 29 patients over a 19-month period ending in December of 1991. All individuals had been unresponsive to conservative treatment and presented with low-back pain in addition to signs and symptoms consistent with neurogenic claudication or radiculopathy. Nine had undergone previous lumbar decompressive surgery. The minimum and mean postoperative follow-up times were 2 and 2 1/2 years, respectively. The mean patient age was 64 years; only two patients were younger than 50 years of age.
Of the patients with neurogenic claudication, 69% reported complete pain relief at follow-up review. Of those with radicular symptoms, 41% had complete relief and 23% had mild residual pain that was rated 3 or less on a pain—functionality scale of 0 to 10. For the entire sample, this surgery decreased pain from 9.2 to 3.3 (p < 0.0001) on the scale. Sixty-nine percent of patients were satisfied with surgery. Low-back pain was significantly relieved in 62% of all patients (p < 0.0001). Low-back pain relief correlated negatively with number of levels decompressed (p < 0.05). To assess fusion, follow-up flexion/extension radiographs were obtained, and no motion was detected at the surgically treated levels in any patient.
The results suggest that this decompression procedure safely and successfully treats not only the radicular symptoms caused by lateral stenosis but also the neurogenic claudication symptoms associated with central stenosis. In addition, the procedure, by using contralateral autologous bone fusion along the laminae and spinous processes, can preserve stability without instrumentation.
Abstracts of the 2013 Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves
Phoenix, Arizona • March 6–9, 2013
Christopher S. Bailey, Marcel F. Dvorak, Kenneth C. Thomas, Michael C. Boyd, Scott Paquett, Brian K. Kwon, John France, Kevin R. Gurr, Stewart I. Bailey and Charles G. Fisher
The authors compared the outcome of patients with thoracolumbar burst fractures treated with and without a thoracolumbosacral orthosis (TLSO).
As of June 2002, all consecutive patients satisfying the following inclusion criteria were considered eligible for this study: 1) the presence of an AO Classification Type A3 burst fractures between T-11 and L-3, 2) skeletal maturity and age < 60 years, 3) admission within 72 hours of injury, 4) initial kyphotic deformity < 35°, and 5) no neurological deficit. The study was designed as a multicenter prospective randomized clinical equivalence trial. The primary outcome measure was the score based on the Roland-Morris Disability Questionnaire assessed at 3 months postinjury. Secondary outcomes are assessed until 2 years of follow-up have been reached, and these domains included pain, functional outcome and generic health-related quality of life, sagittal alignment, length of hospital stay, and complications. Patients in whom no orthotic was used were encouraged to ambulate immediately following randomization, maintaining “neutral spinal alignment” for 8 weeks. The patients in the TLSO group began being weaned from the brace at 8 weeks over a 2-week period.
Sixty-nine patients were followed to the primary outcome time point, and 47 were followed for up to 1 year. No significant difference was found between treatment groups for any outcome measure at any stage in the follow-up period. There were 4 failures requiring surgical intervention, 3 in the TLSO group and 1 in the non-TLSO group.
This interim analysis found equivalence between treatment with a TLSO and no orthosis for thoracolumbar AO Type A3 burst fractures. The influence of a brace on early pain control and function and on long-term 1- and 2-year outcomes remains to be determined. However, the authors contend that a thoracolumbar burst fracture, in exclusion of an associated posterior ligamentous complex injury, is inherently a very stable injury and may not require a brace.