Effect of Denosumab on Osteolytic Lesion Activity after Total Hip Arthroplasty: A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Concept Study

2020 ◽  
Author(s):  
Mohit Mahatma ◽  
Raveen Jayasuriya ◽  
David Hughes ◽  
Nigel Hoggard ◽  
Simon Buckley ◽  
...  
2019 ◽  
Vol 101-B (2) ◽  
pp. 207-212 ◽  
Author(s):  
A. Clavé ◽  
R. Gérard ◽  
J. Lacroix ◽  
C. Baynat ◽  
M. Danguy des Déserts ◽  
...  

Aims Cementless primary total hip arthroplasty (THA) is associated with risks of bleeding and thromboembolism. Anticoagulants are effective as venous thromboprophylaxis, but with an increased risk of bleeding. Tranexamic acid (TXA) is an efficient antifibrinolytic agent, but the mode and timing of its administration remain controversial. This study aimed to determine whether two intravenous (IV) TXA regimens (a three-hour two-dose (short-TXA) and 11-hour four-dose (long-TXA)) were more effective than placebo in reducing perioperative real blood loss (RBL, between baseline and day 3 postoperatively) in patients undergoing THA who receive rivaroxaban as thromboprophylaxis. The secondary aim was to assess the non-inferiority of the reduction of blood loss of the short protocol versus the long protocol. Patients and Methods A multicentre, prospective, randomized, double-blind, placebo-controlled trial was undertaken involving 229 patients undergoing primary cementless THA using a posterior approach, whose extended rivaroxaban thromboprophylaxis started on the day of surgery. There were 98 male and 131 female patients, with a mean age of 65.5 years (32 to 91). The primary outcome, perioperative RBL, was evaluated at 72 hours postoperatively. The efficacy of short- and long-TXA protocols in the reduction of perioperative RBL was compared with a placebo group. Results TXA significantly reduced perioperative blood loss compared with placebo (p < 0.001); the mean differences were 525.3 ml (short-TXA vs placebo) and 550.1 ml (long-TXA vs placebo). No venous or arterial thromboembolic complications were reported. The upper boundary of the 95% confidence interval, when comparing short and long protocols, was below the pre-specified margin of non-inferiority (p = 0.027). Conclusion In patients undergoing primary cementless THA, using a posterior approach, who are treated with rivaroxaban for thromboembolic prophylaxis, short- and long-TXA IV protocols are significantly more effective than placebo in reducing perioperative RBL, without any thromboembolic complications. Non-inferiority of a short- versus a long-TXA protocol in reducing perioperative RBL was supported in a secondary analysis.


2018 ◽  
Vol 1 (21;1) ◽  
pp. 483-488
Author(s):  
Xi-sheng Weng

Background: Total hip arthroplasty (THA) is a well-accepted surgical treatment for terminal hip diseases. Objective: To evaluate the effect of preemptive analgesia with parecoxib in patients undergoing primary unilateral THA. Study Design: A randomized, double-blind, placebo-controlled study. Setting: This study was conducted at Peking Union Medical College Hospital and Beijing Jishuitan Hospital in Beijing, China. Methods: A total of 94 patients scheduled for primary unilateral THA in 2 centers (Peking Union Medical College Hospital and Beijing Jishuitan Hospital) were randomly assigned to receive 40 mg parecoxib (n = 48) or 0.9% normal saline solution (n = 46) 30 minutes before incision. All patients received standardized intravenous patient-controlled analgesia (PCA) postoperatively. Preoperative baseline data, surgery-related conditions, postoperative Visual Analog Scale (VAS) pain score, cumulative narcotic consumption of PCA, and complications were compared between the parecoxib group and the placebo group. Results: There were no significant differences in postoperative VAS pain score, cumulative narcotic consumption of PCA, proportion of analgesic remedy, and complications between the 2 groups. Limitations: Only a single dose of parecoxib was used without including a dose-dependent control group. Conclusion: A single dose of parecoxib 30 minutes before incision did not provide effective preemptive analgesia for the management of postoperative pain after primary unilateral THA. The possible effect of preemptive analgesia with parecoxib needs further investigation. Key words: Total hip arthroplasty, pain, parecoxib, COX-2 selective inhibitor, preemptive analgesia, clinical trial, patient-controlled analgesia, analgesics


2013 ◽  
Vol 110 (1) ◽  
pp. 66-73 ◽  
Author(s):  
T.H. Lunn ◽  
L.Ø. Andersen ◽  
B.B. Kristensen ◽  
H. Husted ◽  
L. Gaarn-Larsen ◽  
...  

2016 ◽  
Vol 31 (6) ◽  
pp. 1208-1212 ◽  
Author(s):  
Peter K. Sculco ◽  
Alexander S. McLawhorn ◽  
Natasha Desai ◽  
Edwin P. Su ◽  
Douglas E. Padgett ◽  
...  

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