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IRCT20200305046700N1 IRCT 2020-04-25 Tehran University of Medical Sciences The Effect of Bone Wax on Controlling Blood Loss during Total Hip Replacement Surgery The Efficacy of Bone Wax Application following Femoral Neck Osteotomy in Controlling Blood Loss in Total Hip Arthroplasty via Direct Anterior Approach 2020-05-21 anticipated 100 Complete https://irct.ir/trial/47400 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Each included patient is assigned a unique number. Using the permuted balanced block method and randomization formula in Microsoft Office Excel 365 software, we will create the table of randomized allocation of the patients into two groups of the study (intervention or control). There will be an equal chance of being randomly assigned to each of the two groups of the study. We will assume six blocks of four (AABB, BBAA, ABAB, BABA, ABBA, BAAB). The patients will be divided into sequentially numbered groups of four. The groups will be entered into a column in MS Excel sheet. In the next column, the blocks are entered in order until the patients' groups are finished. Then, the blocks will be randomized using the Randl() formula. The block in front of each group determines the intervention group (A, B) for the members of that group, for example, for block AABB, the 1st patient will be assigned to group A, 2nd patient A, 3rd patient B, and 4th patient B. Therefore, each patient will be randomly allocated to one of the two intervention groups of the study, i.e., intervention (A) or control (B), based on his unique number, Blinding description: In this study, the patient is not aware of his intervention group, hence the blinding of the patient. The group of each patient is assigned to his case report formula as a removable folded label. It will be opened in the operation room and discarded subsequently after the surgeon becomes aware of the intervention group of the patient. Therefore, the outcome assessor physician, who will collect data regarding blood loss and other clinical data, will not be aware of the intervention group of the patients, hence the blinding of the outcome assessor physician. Finally, the data analyzer will not also be aware of the intervention group of the patients. He will analyze the data based on A and B groups and after the end of data analysis, the A and B groups will be decoded. Thus, this trial will be triple-blinded. N/A Primary hip degenerative joint disease. Intervention 1: Intervention group: Intervention is defined as temporary application of appropriate amount -2.5 gr- of bone wax on the cut surface of femoral neck right after femoral neck osteotomy until the broaching of femur is performed. Subsequently the bone wax is discarded. Intervention 2: Control group: In this group, the routine total hip arthroplasty is performed without using bone wax. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Mohammadreza Razzaghof
Joint Reconstruction Research Center, Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1586 m.razzaghof@gmail.com Tehran University of Medical Sciences scientific Mohammadreza Razzaghof
Joint Reconstruction Research Center, Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1586 m.razzaghof@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with hip degenerative joint disease (ICD-10-CM ; M16) with no age and sex limits, and not considering the severity of the disease, who are candidates for elective primary total hip arthroplasty based on the clinical and radiographic workup The patients should complete and sign the informed consent formula. The anesthesia method should be spinal anesthesia. no limit no limit Both Any bleeding disorder (ICD-10-CM; D65-D69) including platelet disorders like von Willebrand disease, and coagulation disorders like hemophilia History of venous thromboembolic accidents like deep vein thrombosis (DVT), pulmonary thromboembolism (PTE), cerebrovascular accidents (CVA), and myocardial infarction (MI) High-risk medical comorbidities like chronic kidney disease (GFR< 60 mL/min), liver, and heart failure (NYHA classes III , IV) Inflammatory arthritis of hip joint (ICD-10-CM; M05-M14) like rheumatoid arthritis Total hip arthroplasty due to acute proximal femoral fracture Total hip arthroplasty due to developmental dysplasia of hip (DDH) type II and more Revision total hip arthroplasty The use of antithrombotic drugs (ATC code; B01) including vitamin K antagonists (B01AA) like warfarin, platelet aggregation inhibitors (B01AA) like clopidogrel, heparin group (B01AB), Factor X inhibitors (B01AF) like rivaroxaban, direct thrombin inhibitors (B01AE) like dabigatran Impaired coagulation laboratory profile including INR>1.1, aPTT> 1.4, PT> 13.5, or thrombocytopenia < 150,000 per microliter Any anesthesia method other than spinal anesthesia Patient cannot or do not want to continue participating in the study or follow-up for any reason M16.10 Unilateral primary osteoarthritis, unspecified hip Treatment - Surgery Treatment - Surgery Intervention group: Intervention is defined as temporary application of appropriate amount -2.5 gr- of bone wax on the cut surface of femoral neck right after femoral neck osteotomy until the broaching of femur is performed. Subsequently the bone wax is discarded Control group: In this group, the routine total hip arthroplasty is performed without using bone wax. Apparent blood loss. Timepoint: At the end of operation. Method of measurement: Apparent blood loss is defined as the sum of blood in the suction bottle and blood absorbed in the used long gauze pads. The volume of blood absorbed within the long gauze pads is calculated by the difference between the weight of soaked and dry long gauze pads divided by blood density (1.060 gr/mL). Total blood loss. Timepoint: The 3rd and 5th post-operative days. Method of measurement: Nadler formula is used total blood volume of each patient: TBV [mL] = (0.0003669 × height3[cm]) + (32.19 × body weight [Kg]) + 604 (for males) TBV [mL] = (0.0003561 × height3[cm]) + (33.08 × body weight [Kg]) + 183 (for females) Mercuriali formula is used to calculate total blood loss based on pre- and post-operative (3rd and 5th days) hematocrits: Estimated Blood Loss [mL] = TBV [mL] * (Hctpreop- HctPOD5) + Transfused pRBC volume [mL] Good formula is used to calculate total blood loss based on pre- and post-operative (3rd and 5th days) hemoglobins: Hb_loss [gr]=TBV[mL]×(Hb_preop [gr/dL]-Hb_postop [gr/dL])×0.01[dL/mL]+Hb_t [gr]Total Blood Loss(mL)=(Hb_loss [gr]×100(mL/dL))/(Hb_preop [gr/dL]). Safety. Timepoint: On postoperative follow-up at least for 6 months. Method of measurement: Clinical and radiographic assessment of the patient over the postoperative follow-up. Need for transfusion of packed-RBCs. Timepoint: During the surgery or the admission period following surgery. Method of measurement: The volume of received packed RBCs. Tehran University of Medical Sciences Approved 2020-04-15 Ethics committee of Imam Khomeini Hospital Complex/ Tehran University of Medical Sciences Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway Tehran Tehran Iran (Islamic Republic of)