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Prospective randomised evaluation of a collagen/thrombin and autologous platelet haemostatic agent during cementless total hip arthroplasty.

ABSTRACT: Total hip arthroplasty (THA) can be associated with substantial peri-operative blood loss which can negatively influence a patient's clinical outcome. Few haemostatic agents have been tested in THA. The aim of this study was to determine whether the use of a collagen/thrombin/ autologous platelet haemostatic agent would result in a significant decrease of blood transfusions for patients undergoing primary THA.THA patients meeting inclusion/exclusion criteria (n=109) were enrolled in this prospective, double-blind trial and randomised to a treatment arm (standard haemostatic methods plus haemostatic agent) or control arm (standard haemostatic methods only). The primary outcome was transfusion. Secondary outcome measures included peri-operative narcotic usage and post-operative haemoglobin levels, pain scores, function, and general health quality of life.Transfusions were required by 5/60 (8.3%) patients in the treatment group and 7/49 (14.3%) in the control group (p=0.33). The mean number of units transfused was not significantly different between the treatment group (2.2±1.3) and the control group (1.6±0.5) (p=0.36). Haemoglobin values on post-operative days 1, 2, and 3 were significantly higher in the treatment group (p=0.002, 0.04, and 0.02, respectively). Hip Disability and Osteoarthritis Outcome Score and Short Form-12 scores were not different between the two groups.In relatively healthy patients undergoing primary cementless THA there was no significant difference in number of transfusions or number of units transfused. It is unlikely that we will routinely use the investigated haemostatic agent to reduce blood loss in a healthy patient undergoing THA. The product may have some benefit in patients who refuse blood transfusions, have minimal ability to increase blood volume, are undergoing total joint revision, or have markedly low pre-operative haemoglobin levels, but this needs to be demonstrated.

SUBMITTER: Joyce DM

PROVIDER: S-EPMC4614299 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Prospective randomised evaluation of a collagen/thrombin and autologous platelet haemostatic agent during cementless total hip arthroplasty.

Joyce David M DM Klika Alison K AK Mutnal Amar A Krebs Viktor V Molloy Robert R Knothe Ulf U Barsoum Wael K WK

Blood transfusion = Trasfusione del sangue 20150421 3

<h4>Background</h4>Total hip arthroplasty (THA) can be associated with substantial peri-operative blood loss which can negatively influence a patient's clinical outcome. Few haemostatic agents have been tested in THA. The aim of this study was to determine whether the use of a collagen/thrombin/ autologous platelet haemostatic agent would result in a significant decrease of blood transfusions for patients undergoing primary THA.<h4>Materials and methods</h4>THA patients meeting inclusion/exclusi ...[more]

PMID: 26057484

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Project description:Mortality related to femoral neck fractures remains a challenging health issue, with a high mortality rate at 1 year of follow-up. Three modifiable factors appear to be under control of the surgeon: the choice of the implant, the use of cement and the timing before surgery. The aim of this research project was to study the impact on mortality each of these risk factors play during the management of femoral neck fractures. A large retrospective epidemiological study was performed using a national database of the public healthcare system. The inclusion criteria were patients who underwent joint replacement surgery after femoral neck fracture during the years 2015 to 2017. All data points were available for at least 2 years after the fracture. The primary outcome was mortality within 2 years following the surgery. We evaluated the association between mortality and the type of the implant hemiarthroplasty (HA) versus total hip arthroplasty (THA), cemented versus non cemented femoral stem as well as the timing from fracture to surgical procedure. A multivariate analysis was performed including age, gender, comorbidities/autonomy scores, social category, and obesity. We identified 96,184 patients who matched the inclusion criteria between 2015 and 2017. 64,106 (66%) patients underwent HA and 32,078 (33.4%) underwent THA. After multivariate analysis including age and comorbidities, patients who underwent surgery after 72 h intra-hospital had a higher risk of mortality: Hazard Ratio (HR) = 1.119 (1.056-1.185) p = 0.0001 compared to the group who underwent surgery within 24 h. THA was found to be a protective factor HR = 0.762 (0.731-0.795) p < 0.0001. The use of cement was correlated with higher mortality rate: HR = 1.107 (1.067-1.149) p < 0.0001. Three key points are highlighted by our study in the reduction of mortality related to femoral neck fracture: the use of hemiarthroplasty a surgery performed after 48 h and the use of cement for femoral stem fixation adversely affect mortality risk.

Project description:Background and purpose - The use of cementless total hip arthroplasty (THA) in elderly patients is debated because of increased risk of early periprosthetic femoral fractures. However, cemented femoral components carry a risk of bone cement implantation syndrome. Hence, we compared in-hospital complications, complications leading to readmission and mortality ≤ 30 days postoperatively between hybrid/cemented (cemented femoral component) vs. cementless THA in osteoarthritis patients > 70 years.Patients and methods - This is a prospective observational cohort study in 9 centers from January 2010 to August 2017. We used 30-day follow-up from the Danish National Patient Registry, patient records, and data from the Danish Hip Arthroplasty Register. Only THAs performed as a result of osteoarthritis were included.Results - 3,368 (42%) of the THAs were cemented/hybrid and 4,728 (58%) cementless. The in-hospital complication risk was 7.7% after cemented/hybrid vs. 5.3% after cementless THA (< 0.001), statistically not significant when adjusting for comorbidities (p = 0.1). There were similar risks of complications causing readmission (5.7% vs. 6.2%) and mortality ≤ 30 days (0.2% vs. 0.3%). 15 cases (0.4%) of pulmonary embolism (PE) were found after cemented/hybrid vs. 4 (0.1%) after cementless THA (p = 0.001); none occurred within 24 hours postoperatively. 2 of the PEs after cementless THA led to mortality. Cemented/hybrid THA remained significantly associated with risk of PE (RR 3.9, p = 0.02), when adjusting for comorbidities. BMI > 35 was associated with highest risk of PE (RR 5.7, p = 0.003). The risk of periprosthetic femoral fracture was 0.2% after cemented/hybrid vs. 1.5% after cementless THA (p < 0.001) and the risk of dislocations was 1.2% after cemented/hybrid THA vs. 1.8% after cementless THA (p = 0.04).Interpretation - The higher risk of PE after cemented/hybrid THA and higher risk of periprosthetic femoral fractures and dislocations after cementless THA highlights that both medically and surgically complications are related to fixation technique and have to be considered.

Dataset Information

Prospective randomised evaluation of a collagen/thrombin and autologous platelet haemostatic agent during cementless total hip arthroplasty.

Publications

Prospective randomised evaluation of a collagen/thrombin and autologous platelet haemostatic agent during cementless total hip arthroplasty.

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