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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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 Comparative Study
The effect of autologous fibrin tissue adhesive on postoperative cerebrospinal fluid leak in spinal cord surgery: a randomized controlled trial.
A prospective randomized study evaluating the efficacy of autologous fibrin tissue adhesive for decreasing postoperative cerebrospinal fluid (CSF) leak in spinal cord surgery. ⋯ We used autologous fibrin tissue adhesive as a new sealant after dural closure instead of commercial fibrin tissue adhesive. No definitive CSF leak was observed, and the volume of drainage fluid was significantly lower in the group with autologous fibrin tissue adhesive than that in the group without fibrin tissue adhesive. The use of autologous fibrin tissue adhesive was superior to that of commercial fibrin tissue adhesive in cost.