Efficacy and Safety of Retrograde Intraarticular Injection, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Femoral Neck Fractured Patients Undergoing Cementless Bipolar Hemiarthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-03

Study Completion Date

2026-04-30

Brief Summary

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The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:

* The efficacy in reducing blood transfusion for topical tranexamic acid administration
* The safety of tranexemic acid, topically used

As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.

Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.

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Detailed Description

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Conditions

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Femoral Neck Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Retrograde Intraarticular Injection via Drain Tube

Tranexamic acid will be injected retrograde to the joint via drain tube after surgical wound closure

Group Type EXPERIMENTAL

Topical tranexamic acid administration

Intervention Type DRUG

Tranexamic acid will be topically administered in intervention groups

Topical Soaking of Tranexamic Acid

Tranexamic acid will be placed to soak the intramedullary canal of the femur and surgical area after sheath closure for 5 minutes and completely remove by sunction

Group Type EXPERIMENTAL

Topical tranexamic acid administration

Intervention Type DRUG

Tranexamic acid will be topically administered in intervention groups

Standard procedure (placebo)

Standard wound irrigation

Group Type PLACEBO_COMPARATOR

Topical tranexamic acid administration

Intervention Type DRUG

Tranexamic acid will be topically administered in intervention groups

Interventions

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Topical tranexamic acid administration

Tranexamic acid will be topically administered in intervention groups

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elderly patients (age \> 60 years)
* Femoral neck fractures from low energy mechanism
* Household ambulator
* Undergoing cementless bipolar hemiarthroplasty at KCMH
* Informed consent

Exclusion Criteria

* Allergy to TXA
* History of VTE
* History of hip surgery, pathological fracture, hip infection
* Congenital or acquired coagulopathy
* Hb \< 10 g/dL or Platelet \< 140,000

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes