Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty on Postoperative Pain and Range of Motion: A Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: t
View:

• \- All patients undergoing either manual or robotic primary total knee arthroplasty (TKA)

• Performed by participating Connecticut Joint Replacement Institute (CJRI) surgeons (Dr. Matthew Grosso, Dr. Robert McAllister, Dr. Chad Daniel, Dr. Eric Silverstein, Dr. Alex Dukas, Dr. Michael Joyce, Dr. Brett Wasserlauf).

• Male and female patient age 18-89

• Primary diagnosis of knee osteoarthritis

Locations
United States
Connecticut
Trinity Health Of New England/CT Joint Replacement Institute
RECRUITING
Hartford
Contact Information
Primary
Gina Panek, BS
gpanek@trinityhealthofne.org
860-714-4164
Backup
Czarina Weinz
Czarina.Weinz@trinityhealthofne.org
860-714-0467
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2025-03-30
Participants
Target number of participants: 80
Treatments
Active_comparator: TXA
\- 1.95 grams oral TXA (tranexamic acid) (3- 650 mg tablets) administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.
Placebo_comparator: Placebo
\- 3 tablets administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.
Related Therapeutic Areas
Sponsors
Leads: Matthew Grosso, MD

This content was sourced from clinicaltrials.gov