ABSTRACT
BACKGROUND: Posterior lumbar interbody fusion is the main repair method for senile degenerative lumbar spondylolisthesis. For elderly patients with osteoporosis, single screw rod system fixation regularly results in dislocation. The incidence of implant loosening is high, and therefore, effective internal fixation is not achieved. OBJECTIVE: This study will use the modified posterior lumbar interbody fusion procedure combined with bone cement augmentation for the treatment of senile degenerative lumbar spondylolisthesis so as to increase the stability of the vertebral body, make the fixator firm, and to maximize the recovery of postoperative motor function. METHODS: Totally 113 patients with senile degenerative lumbar spondylolisthesis, aged 65-70 years, irrespective of sex, will be recruited from the Department of Orthopedics of Affiliated Hospital of Qinghai University of China. The patients will be treated with modified posterior lumbar interbody fusion combined with bone cement augmentation. Follow-up will be performed at 3 and 12 months. The primary outcome measure is recovery of motor function as indicated by the postoperative Oswestry Disability Index score at 12 months. The secondary outcome measures are the change in the rate of excellent and good Oswestry Disability Index scores (comparing preoperative scores with the 4-month postoperative scores), Visual Analogue Scale scores, intervertebral space height, foraminal height, the preoperative and 4 and 14 months postoperative slip distance and slip angle, incidence of adverse reactions, success rate of vertebral fusion, and incidence of secondary slip 4 and 14 months postoperatively. This trial has been approved by the Medical Ethics Committee of Affiliated Hospital of Qinghai University of China(approval number:QHY023G).The study protocol will be proformed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. This trial was designed in October 2017. The recruitment of subjects and data collection will begin in June 2018. The recruitment will be finished in December 2018. Outcome measures will be analyzed in January 2020. This trial will be completed in February 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800015335). Protocol version (1.0). DISCUSSION: This trial aims to observe the efficacy of modified posterior lumbar interbody fusion combined with bone cement augmentation in the treatment of senile degenerative lumbar spondylolisthesis and to validate whether the procedure is safe and reliable.
ABSTRACT
BACKGROUND: Percutaneous kyphoplasty is an effective treatment method for senile degenerative thoracic osteoporotic vertebral compression fractures. However, its clinical long-term effect is controversial among scholars both inside and outside China. The poly(methyl methacrylate) (PMMA) bone cement commonly used in percutaneous kyphoplasty has good plasticity and formability, but its biocompatibility is not yet clear. Injectable artificial bone is a novel filling material to induce bone formation, but its long-term efficacy remains to be verified. OBJECTIVE: To compare the efficacy of OSTEOPAL?Plus PMMA bone cement and GeneX? injectable artificial bone graft in the treatment of senile degenerative thoracic osteoporotic vertebral compression fractures at 24 months postoperatively. METHODS: This is a prospective, single-center, open-label, randomized controlled clinical trial. A total of 378 patients with senile degenerative thoracic osteoporotic vertebral compression fractures will be recruited from the Department of Orthopedics, Affiliated Hospital of Qinghai University, China. The patients will be randomized into two groups and undergo percutaneous kyphoplasty. The PMMA group (n=189) will be treated with OSTEOPAL?Plus PMMA bone cement. The artificial bone group (n=189) will be treated with GeneX? injectable artificial bone. Follow-ups will be conducted at 1 week and at 3, 6, 12, and 24 months. The primary outcome measure will be the vertebral body height restoration rate at 24 months postoperatively to evaluate the repair effect of the damaged thoracic vertebra. The secondary outcome measures will be the vertebral body height restoration rate at 1 week and 3, 6, and 12 months postoperatively; the incidence of bone cement leakage at 1 week and 3, 6, 12, and 24 months postoperatively; the visual analog scale score, Oswestry Disability Index, compression rate of the anterior vertebral height, and thoracic morphology revealed by computed tomography preoperatively and at 1 week and 3, 6, 12, and 24 months postoperatively; and the incidence of adverse reactions at 1 week and 3, 6, 12, and 24 months postoperatively. DISCUSSION: Our results will verify whether OSTEOPAL?Plus PMMA bone cement and GeneX? injectable artificial bone graft are effective and safe for treating senile degenerative thoracic osteoporotic vertebral compression fractures in the short-term and at the 2-year follow-up. This study was approved by the Medical Ethics Committee of Affiliated Hospital of Qinghai University of China in November 2017 (approval number: 2017-11). The study protocol will be conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants who will be fully informed of study protocol and process. This trial was designed in December 2017. The recruitment of subjects and data collection will begin in July 2018. Outcome measures will be analyzed in September 2020. This trial will be completed in October 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial had been registered in the Chinese Clinical Trial Registry (registration No:ChiCTR1800015411). The version of this study protocol is 1.0.
ABSTRACT
<p><b>BACKGROUND</b>Epinephrine infiltration of the nasal mucosa causes hypotension during functional endoscopic sinus surgery (FESS) under general anesthesia. A prospective randomized-controlled study was designed to determine whether relatively light general anesthesia is superior to fluid expansion in reducing epinephrine-induced hypotension during FESS.</p><p><b>METHODS</b>Ninety patients undergoing elective FESS under general anesthesia were randomly assigned to three groups with 30 patients in each. Each patient received local infiltration with adrenaline-containing (5 microg/ml) lidocaine (1%, 4 ml) under different conditions. For Group I, anesthesia was maintained with propofol 2 microg/ml and rimifentanil 2 ng/ml by TCI. Group II (control group) and Group III received propofol 4 microg/ml and rimifentanil 4 ng/ml, respectively. In Groups I and II, fluid expansion was performed with hetastarch 5 ml/kg within 20 minutes; hetastarch 10 ml/kg was used in Group III. Mean arterial pressure (MAP) and heart rate (HR) were recorded at 30-second-intervals for 5 minutes after the beginning of local infiltration. Simultaneously, the lowest and the highest MAP were recorded to calculate the mean maximum increase or decrease percent in MAP for all patients in each group. Data analysis was performed by chi(2) test, one-way analysis of variance, or one-way analysis of covariance.</p><p><b>RESULTS</b>Hemodynamic changes, particularly a decrease in MAP accompanied by an increase in HR at 1.5 minutes (P < 0.05), were observed in all groups. The mean maximum decrease in MAP below baseline was 14% in Group I, 24% in Group III and 26% in Group II. There were statistically significant differences between Group I and Groups II and III (P < 0.05). The mean maximum increase in MAP above baseline was 9% in Group I, 6% in Group III and 2% in Group II.</p><p><b>CONCLUSION</b>Relatively light general anesthesia can reduce the severity of epinephrine-induced hypotension more effectively than fluid expansion during FESS under general anesthesia.</p>