Spine
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Randomized Controlled Trial Multicenter Study Comparative Study
A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes.
A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. ⋯ This prospective, randomized, multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITE artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion. These results support earlier reports in the literature that total disc replacement with the CHARITE artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients. The CHARITE artificial disc group demonstrated statistically significant superiority in two major economic areas, a 1-day shorter hospitalization, and a lower rate of reoperations (5.4% compared with 9.1%). At 24 months, the investigational group had a significantly higher rate of satisfaction (73.7%) than the 53.1% rate of satisfaction in the control group (P = 0.0011). This prospective randomized multicenter study also demonstrated an increase in employment of 9.1% in the investigational group and 7.2% in the control group.
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Randomized Controlled Trial Multicenter Study Comparative Study
A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes.
A prospective, randomized, multicenter, Food and Drug Administration-regulated, investigational device exemption clinical trial. ⋯ Preoperative ROM in flexion/extension was restored and maintained in patients receiving a TDR. TDR with the CHARITE artificial disc resulted in significantly better restoration of disc space height, and significantly less subsidence than anterior interbody fusion with BAK cages. Clinical outcomes and flexion/extension ROM correlated with surgical technical accuracy of CHARITE artificial disc placement. In the majority of cases, placement of the CHARITE artificial disc was ideal.
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Comparative Study
Spinopelvic alignment in patients with osteoarthrosis of the hip: a radiographic comparison to patients with low back pain.
A retrospective, age- and sex-matched radiographic study. ⋯ These findings suggest that higher PI in the younger individual may contribute to the development of HOA in later life without both lumbar kyphosis and acetabular dysplasia because of the anterior uncovering of the acetabulum. More investigation will be expected to analyze the spinopelvic alignment in patients with hip spine syndrome.
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A porous tantalum implant (Hedrocel, Implex Corp., Allendale, NJ), designed to assist interbody lumbar fusion, was tested biologically in an experimental model. A total of 11 female Danish landrace pigs received 3 levels of anterior lumbar interbody fusion at L2-L3, L4-L5, and L6-L7. Each level was randomly assigned one of the procedures: (1) implantation of PT-ring with pedicle screw fixation (PSF), (2) implantation of a porous tantalum ring (PT-ring) stabilized anteriorly with staples, or (3) implantation of carbon fiber cage (CF-cage) stabilized anteriorly with 2 staples. Each implant was filled with autogenous iliac crest bone graft. ⋯ Interbody fusion using a PT-ring cage packed with autologous bone achieved higher interface healing and more reliable fusion when fixated with supplementary pedicle screws than did fixated anteriorly with 2 staples. A lesser amount of bone graft was required, and bone remodeling was enhanced in the PT-ring when compared to the CF-cage.
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A retrospective study was conducted to investigate the incidence and prognosis of postoperative lumbar nerve root palsy after surgical treatment for adult spinal deformity. ⋯ Patients with increasingly complex spinal deformities are at a higher risk for postoperative lumbar nerve root palsy. These injuries can be treated nonoperatively when there is no identifiable cause on postoperative imaging studies.