BACKGROUND:Blood loss during total hip arthroplasty can be substantial and may lead to adverse patient outcomes and increased health-care costs. Many blood-management options are available for these procedures. The purpose of the present study was to test the hemostatic efficacy of a bipolar sealer used during total hip arthroplasty in order to determine whether its use results in significantly lower transfusion requirements and/or improved clinical, functional, and health-related quality-of-life outcomes in healthy patients. METHODS: This prospective, single-center, randomized, double-blinded study was designed to enroll a total of 140 patients. Patients with a low preoperative hemoglobin level or a history of bleeding abnormalities and other medical conditions were excluded. Patients were randomized to either the treatment arm (radiofrequency energy with use of the Aquamantys 6.0 bipolar sealer) or control arm (standard Bovie electrocautery). The primary outcome measure was the transfusion requirement, and the secondary outcome measures were intraoperative estimated blood loss, postoperative hemoglobin levels, perioperative narcotic usage, length of hospital stay, postoperative pain scores, and postoperative function as measured with the Harris hip score and the Short Form-12 quality-of-life score. RESULTS:Seventy-one patients were assigned to the treatment arm, and sixty-nine were assigned to the control arm. The mean number of units of blood transfused for all patients in the study and control arms were 0.38 and 0.44, respectively (p = 0.72). The transfusion requirements were similar in the two groups, with fifteen of seventy-one patients in the treatment arm and fourteen of sixty-nine patients in the control arm requiring a transfusion (p = 0.9). No significant differences were detected between the groups in terms of estimated blood loss, postoperative hemoglobin levels, perioperative narcotic usage, length of hospital stay, postoperative pain scores, Harris hip scores, or Short Form-12 scores. CONCLUSIONS: In this patient population, there were no significant differences between the treatment and control groups in terms of the need for blood transfusions or overall blood loss. Given these findings, we have discontinued the use of this bipolar sealing device in uncomplicated primary total hip arthroplasty patients at our institution. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
RCT Entities:
BACKGROUND:Blood loss during total hip arthroplasty can be substantial and may lead to adverse patient outcomes and increased health-care costs. Many blood-management options are available for these procedures. The purpose of the present study was to test the hemostatic efficacy of a bipolar sealer used during total hip arthroplasty in order to determine whether its use results in significantly lower transfusion requirements and/or improved clinical, functional, and health-related quality-of-life outcomes in healthy patients. METHODS: This prospective, single-center, randomized, double-blinded study was designed to enroll a total of 140 patients. Patients with a low preoperative hemoglobin level or a history of bleeding abnormalities and other medical conditions were excluded. Patients were randomized to either the treatment arm (radiofrequency energy with use of the Aquamantys 6.0 bipolar sealer) or control arm (standard Bovie electrocautery). The primary outcome measure was the transfusion requirement, and the secondary outcome measures were intraoperative estimated blood loss, postoperative hemoglobin levels, perioperative narcotic usage, length of hospital stay, postoperative pain scores, and postoperative function as measured with the Harris hip score and the Short Form-12 quality-of-life score. RESULTS: Seventy-one patients were assigned to the treatment arm, and sixty-nine were assigned to the control arm. The mean number of units of blood transfused for all patients in the study and control arms were 0.38 and 0.44, respectively (p = 0.72). The transfusion requirements were similar in the two groups, with fifteen of seventy-one patients in the treatment arm and fourteen of sixty-nine patients in the control arm requiring a transfusion (p = 0.9). No significant differences were detected between the groups in terms of estimated blood loss, postoperative hemoglobin levels, perioperative narcotic usage, length of hospital stay, postoperative pain scores, Harris hip scores, or Short Form-12 scores. CONCLUSIONS: In this patient population, there were no significant differences between the treatment and control groups in terms of the need for blood transfusions or overall blood loss. Given these findings, we have discontinued the use of this bipolar sealing device in uncomplicated primary total hip arthroplastypatients at our institution. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
Authors: David M Joyce; Alison K Klika; Amar Mutnal; Viktor Krebs; Robert Molloy; Ulf Knothe; Wael K Barsoum Journal: Blood Transfus Date: 2015-04-21 Impact factor: 3.443