Spine
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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 Clinical Trial
Assessment of curve flexibility in adolescent idiopathic scoliosis.
A prospective comparative evaluation of the commonly accepted or described radiologic techniques to determine curve flexibility in adolescent idiopathic scoliosis (AIS), comparison of the results to those obtained by supine traction radiographs taken with the patient under general anesthesia (UGA) just before surgery and correlation of all findings to surgical correction. ⋯ Fulcrum higher than bending higher than traction with the patient UGA is the order of radiographs for better predicting flexibility and correction in curves between 40 degrees and 65 degrees. Flexibility obtained at traction radiographs with the patient UGA is clearly better in numerical values, and closer to the amount of surgical correction than the amount of flexibility at fulcrum and side-bending radiographs for curves larger than 65 degrees, although not statistically significant as a result of the small number of patients in this group. However, pedicle screw instrumentation provides even more correction than the traction radiographs with the patient UGA. Thus, traction radiographs with the patient UGA may show much better flexibility, especially in more than 65 degrees and rigid curves.
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To analyze patient outcomes and risk factors associated with proximal junctional kyphosis (PJK) in adults undergoing long posterior spinal fusion. ⋯ Incidence of proximal junctional kyphosis was high, but SRS-24 scores were not significantly affected in patients with PJK. The sagittal C7 plumb was not significantly more positive in PJK patients. No patient, radiographic, or instrumentation variables were identified as risk factors for developing PJK.
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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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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.