Health TrialsbyHealthPanel

Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty

ConditionArthroplasty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged > 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)

Written informed consent

Patients undergoing primary THA diagnosis of end-stage osteoarthritis

Patients receiving spinal anesthesia

Disqualifiers

Patients with a TXA allergy

Patients undergoing revision procedures

Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis

Patients receiving general anesthesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral Tranexamic Acid

    Drug

    Subjects will receive a 1.95 g dose of oral TXA at the following timepoints: (1) following ambulation, (2) postoperative day 1, (3) postoperative day 2, and (4) postoperative day 3

Treatment groups

101 Participants
are divided into 2 treatment groups
Group A: Oral tranexamic acidExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Visual Analog Score

The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.

Time frame
Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
2

Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR)

The Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR) is a questionnaire designed to measure outcomes for patients with hip replacements. Results are scored 0-11. 0 = total hip disability, 100 = perfect hip health.

Time frame
Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

Secondary outcomes

1

Hemoglobin

Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin

Time frame
Baseline, prior to discharge, day 3 postoperatively
2

Harris Hip Score (HHS)

The Harris Hip Score (HHS) is a tool used to assess hip function and the results of hip treatments, such as hip replacements. It's a 100-point scale that measures four areas: pain, function, deformity, and range of motion. A higher score indicates less dysfunction and better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, and 90-100 is excellent.

Time frame
Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
3

Short Form Health Survey (SF-12)

The 12-Item Short Form Health Survey (SF-12) is a questionnaire which consists of 12 questions covering physical and mental health domains. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.

Time frame
Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
4

Time to Independent Ambulation

Duration of time post-operation until the subject can walk without any support or assistance, reported in days

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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