Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty

Phase 4

Not yet recruiting

• Conditions: Arthroplasty
• Interventions: Drug: Oral Tranexamic Acid

• Registration Number: NCT06832878
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-25
• Study Start: 2025-06-15
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral tranexamic acid	Oral Tranexamic Acid	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Score	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks	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.
Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR)	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Oxford Hip Score	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks	The Oxford Hip Score (OHS) is a standard patient-reported outcome (PRO) measure, or PROM, developed to assess function and pain in patients undergoing total hip replacement (THR) surgery, particularly in the context of clinical trials. The OHS has also been used for the assessment of patient outcomes, including physical therapy, and use of joint supplements (disease specific and general health measure are two other outcome measures).
Hemoglobin	Baseline, prior to discharge, day 3 postoperatively	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
Harris Hip Score (HHS)	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks	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.
Short Form Health Survey (SF-12)	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks	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 to Independent Ambulation	12 weeks	Duration of time post-operation until the subject can walk without any support or assistance, reported in days

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States