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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200305046700N1
Enrollment
100
Registered
2020-04-25
Start date
2020-05-21
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hip degenerative joint disease. Unilateral primary osteoarthritis, unspecified hip

Interventions

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 un

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 (GFR1.1, 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Razzaghof

Tehran University of Medical Sciences

m.razzaghof@gmail.com+98 21 6658 1586

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026