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Campbell's Operative Orthopaedics, 2013
Campbell's Operative Orthopaedics, 2013
Campbell's Operative Orthopaedics, 2013
Campbell's Operative Orthopaedics, 2008
Transactions of the ASAE, 1966
Spine, 1995
A prospective, multi-center Investigational Device Exemption Study was carried out in the United ... more A prospective, multi-center Investigational Device Exemption Study was carried out in the United States using a pedicle screw and plate system to perform a fusion in patients with degenerative disc disease or spondylolisthesis. The patients' pain function, complications, and fusion status were evaluated and compared with literature controls. To study the safety and efficacy of the ISF pedicle screw/plate system. This article focuses only on those study patients with degenerative disc disease treated with autogenous bone grafts and compares the results to those of similar patients treated without instrumentation, as reported in the literature. Twenty-eight patients were in the subgroup studied--patients with degenerative disc disease who had fusions with autogenous bone graft. This study was conducted at four clinical sites with a 2-year follow-up. Patient follow-up was greater than 95% at all time points. To be considered a patient with degenerative disc disease, radiographs had to demonstrate a collapse of the disc, the presence of bone erosion, or the compression of the vertebrae as the primary spinal abnormality. Spinal fusion must have been the recommended surgical treatment for discogenic pain. The fusion status was evaluated by the operating surgeon and an independent reviewer. After 2 years, this subset of patients (n = 28) with degenerative disc disease who had lumbar/lumbosacral fusion with autogenous bone graft was found to have a pseudarthrosis rate of 0%. Eight articles in the literature were found to be valid noninstrumented literature controls with which this subgroup could be compared. The average pseudarthrosis rate in the control group was 32%. A statistical analysis showed that patients with degenerative disc disease who underwent fusion without pedicle screw instrumentation were over 24 times more likely to have a pseudarthrosis than comparable patients implanted with a pedicle screw/plate system. Regarding the most important goal in performing a spinal fusion--fusion of the spine--the pedicle screw/plate system used in this study was shown to be a safe and efficacious method of facilitating fusion with autogenous bone graft for this patient population.
Journal of The American College of Surgeons, 2007
BACKGROUND: An alternative to embolization or external pelvic fixation (EPF) in patients with mul... more BACKGROUND: An alternative to embolization or external pelvic fixation (EPF) in patients with multiple pelvic fractures and hemorrhage is a pelvic orthotic device (POD), which may easily be placed in the resuscitation area. Little published information is available about its effectiveness. This study evaluated the efficacy of the POD compared with EPF in patients with life-threatening pelvic fractures. STUDY DESIGN: We evaluated patients with blunt pelvic fractures over a 10-year period. Inclusion required multiple pelvic fractures with vascular disruption and severe retroperitoneal hematoma, open book fracture with symphysis diastasis, or sacroiliac disruption with vertical shear. Patients with EPF were compared with those in whom a POD was used. Outcomes included transfusions, hospital stay, and mortality.
Journal of Spinal Disorders, 1996
A total of 18 patients with grade I or II degenerative spondylolisthesis fused three levels or fe... more A total of 18 patients with grade I or II degenerative spondylolisthesis fused three levels or fewer with autogenous bone graft were entered at three clinical sites. After 2 years, these patients were found to have a fusion rate of 89%. A statistical analysis of these results compared with those in the literature showed that patients with spondylolisthesis who underwent fusion with pedicle screw instrumentation were > 3 times more likely to fuse than comparable patients implanted without a pedicle screw/plate system. The pedicle screw/plate system used in this study was shown to be an effective method of facilitating lumbar or lumbosacral fusion with autogenous bone graft for adult patients with a primary indication of grade I or II degenerative spondylolisthesis.
Campbell's Operative Orthopaedics, 2013
Campbell's Operative Orthopaedics, 2013
Campbell's Operative Orthopaedics, 2013
Campbell's Operative Orthopaedics, 2008
Transactions of the ASAE, 1966
Spine, 1995
A prospective, multi-center Investigational Device Exemption Study was carried out in the United ... more A prospective, multi-center Investigational Device Exemption Study was carried out in the United States using a pedicle screw and plate system to perform a fusion in patients with degenerative disc disease or spondylolisthesis. The patients' pain function, complications, and fusion status were evaluated and compared with literature controls. To study the safety and efficacy of the ISF pedicle screw/plate system. This article focuses only on those study patients with degenerative disc disease treated with autogenous bone grafts and compares the results to those of similar patients treated without instrumentation, as reported in the literature. Twenty-eight patients were in the subgroup studied--patients with degenerative disc disease who had fusions with autogenous bone graft. This study was conducted at four clinical sites with a 2-year follow-up. Patient follow-up was greater than 95% at all time points. To be considered a patient with degenerative disc disease, radiographs had to demonstrate a collapse of the disc, the presence of bone erosion, or the compression of the vertebrae as the primary spinal abnormality. Spinal fusion must have been the recommended surgical treatment for discogenic pain. The fusion status was evaluated by the operating surgeon and an independent reviewer. After 2 years, this subset of patients (n = 28) with degenerative disc disease who had lumbar/lumbosacral fusion with autogenous bone graft was found to have a pseudarthrosis rate of 0%. Eight articles in the literature were found to be valid noninstrumented literature controls with which this subgroup could be compared. The average pseudarthrosis rate in the control group was 32%. A statistical analysis showed that patients with degenerative disc disease who underwent fusion without pedicle screw instrumentation were over 24 times more likely to have a pseudarthrosis than comparable patients implanted with a pedicle screw/plate system. Regarding the most important goal in performing a spinal fusion--fusion of the spine--the pedicle screw/plate system used in this study was shown to be a safe and efficacious method of facilitating fusion with autogenous bone graft for this patient population.
Journal of The American College of Surgeons, 2007
BACKGROUND: An alternative to embolization or external pelvic fixation (EPF) in patients with mul... more BACKGROUND: An alternative to embolization or external pelvic fixation (EPF) in patients with multiple pelvic fractures and hemorrhage is a pelvic orthotic device (POD), which may easily be placed in the resuscitation area. Little published information is available about its effectiveness. This study evaluated the efficacy of the POD compared with EPF in patients with life-threatening pelvic fractures. STUDY DESIGN: We evaluated patients with blunt pelvic fractures over a 10-year period. Inclusion required multiple pelvic fractures with vascular disruption and severe retroperitoneal hematoma, open book fracture with symphysis diastasis, or sacroiliac disruption with vertical shear. Patients with EPF were compared with those in whom a POD was used. Outcomes included transfusions, hospital stay, and mortality.
Journal of Spinal Disorders, 1996
A total of 18 patients with grade I or II degenerative spondylolisthesis fused three levels or fe... more A total of 18 patients with grade I or II degenerative spondylolisthesis fused three levels or fewer with autogenous bone graft were entered at three clinical sites. After 2 years, these patients were found to have a fusion rate of 89%. A statistical analysis of these results compared with those in the literature showed that patients with spondylolisthesis who underwent fusion with pedicle screw instrumentation were > 3 times more likely to fuse than comparable patients implanted without a pedicle screw/plate system. The pedicle screw/plate system used in this study was shown to be an effective method of facilitating lumbar or lumbosacral fusion with autogenous bone graft for adult patients with a primary indication of grade I or II degenerative spondylolisthesis.