Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction
- Conditions
- ACL InjuryACL TearsACL Surgery
- Interventions
- Drug: Tranexamic Acid (TXA)Drug: Placebo
- Registration Number
- NCT07115056
- Lead Sponsor
- Campbell Clinic
- Brief Summary
This is a prospective, multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy of oral tranexamic acid (TXA) in improving postoperative outcomes following anterior cruciate ligament reconstruction (ACLR) using patellar tendon autograft in adolescent and young adult patients.
A total of 100 patients, aged 14 to 22 years and undergoing eligible ACLR, will be enrolled across multiple participating sites. Eligible participants will be randomized 1:1 to receive either oral TXA (1.95 g per day, divided into three 650 mg capsules) or placebo (microcrystalline cellulose) once daily from postoperative day 1 to 10, in addition to standard intraoperative care. All participants will receive 1 g IV TXA prior to incision and 1 g IV TXA at closure, per standard surgical protocol.
The primary outcome is improvement in postoperative pain, as measured by the Visual Analog Scale (VAS). Secondary outcomes are knee range of motion, quadriceps strength, isokinetic strength, time to straight leg raise, time to return to sport, International Knee Documentation Committee score, Lyshom score, and morphine milligram equivalents. Participants will be followed through routine postoperative visits at the participating institutions out to one year with a phone call for patient reported outcomes at 2 years.
- Detailed Description
This multi-center, prospective, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the effect of oral tranexamic acid (TXA) on postoperative outcomes following anterior cruciate ligament reconstruction (ACLR) using bone-tendon-bone (BTB) autograft in adolescent and young adult patients.
Background:
Tranexamic acid is a synthetic antifibrinolytic agent that competitively inhibits plasminogen activation, helping to reduce bleeding. IV TXA is routinely used during orthopedic procedures, including ACLR, and has been shown to reduce intraoperative blood loss. However, the benefit of extending antifibrinolytic coverage with oral TXA in the early postoperative period has not been well studied in this population. This trial aims to investigate whether a 10-day postoperative course of oral TXA improves pain and recovery outcomes following ACLR.
Study Design:
Participants will be randomized in a 1:1 ratio to receive either oral TXA or a placebo. Randomization will be conducted using computer-generated allocation. Both the participants and the study team will remain blinded to group assignment.
Group A (Placebo): Participants will receive 10 doses (30 capsules total) of microcrystalline cellulose (placebo), to be taken daily from postoperative day (POD) 1 through POD 10.
Group B (Oral TXA): Participants will receive 10 doses (30 capsules total) of oral TXA, dosed at 1.95 g per day (650 mg per capsule, 3 capsules daily) from POD 1 through POD 10.
All participants will receive standard intraoperative care, including 1 gram IV TXA prior to skin incision and an additional 1 gram IV TXA at surgical closure. Postoperative pain management will be administered per standard clinical practice and at the discretion of the treating surgical team.
Patient Population:
The study will enroll 100 patients aged 14 to 22 years undergoing isolated ACLR with a BTB autograft at Campbell Clinic Surgery Center and collaborating study sites.
Study Procedures:
Eligible patients will be identified via chart review and approached in clinic or via phone. Informed consent (and assent where applicable) will be obtained during a routine preoperative visit. Baseline data will be collected, including demographics and medical history. Participants will then be randomized and provided with study medication (oral TXA or placebo) to begin on POD 1.
Outcomes: The primary outcome is improvement in postoperative pain, as measured by the Visual Analog Scale (VAS). Secondary outcomes are knee range of motion, quadriceps strength, isokinetic strength, time to straight leg raise, time to return to sport, International Knee Documentation Committee score, Lyshom score, and morphine milligram equivalents.
Blinding and Allocation:
All capsules will be identical in appearance and packaging to maintain blinding. Randomization will be performed centrally and allocation concealed. Study staff, treating physicians, and patients will remain blinded until data analysis.
Safety Monitoring:
Participants will be monitored for adverse events throughout the study period. TXA is generally well tolerated but may pose thrombotic risk in susceptible individuals; exclusion criteria are designed to minimize this risk. The study team will report any serious adverse events (SAEs) to the IRB per institutional guidelines.
The study is powered to detect clinically meaningful differences in VAS scores, with a planned enrollment of 50 patients per group, allowing for a 20% loss to follow-up. This trial aims to clarify the role of extended postoperative oral TXA in reducing inflammation, pain, and bleeding in young ACLR patients, potentially offering a low-cost adjunct to current perioperative care.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 14-22 year old individuals with ACL tear undergoing primary ACLR with patellar tendon autograft.
- Closed or closing proximal tibial and distal femoral physes on pre-operative radiographs (less than one year of growth remaining based on MRI and radiographic bone age assessment)
- Fluent in English
- Willing to participate
- Patient weight greater than or equal to 100lbs (45.4kg)
- Revision ACLR, multi-ligamentous knee reconstruction, inclusion of lateral extra-articular tenodesis (LET) or Anterolateral Ligament (ALL) reconstruction
- Concomitant meniscal repair or chondral preservation surgery requiring postoperative limited weightbearing status (nonweightbearing or partial weightbearing)
- Have a prior history of deep vein thrombosis (DVT) or thromboembolic event
- Known allergy or hypersensitivity to TXA
- Using combination hormonal contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral TXA Tranexamic Acid (TXA) Participants in this arm will receive oral tranexamic acid (TXA), 1.95 g daily (three 650 mg capsules) from POD 1 to POD 10, for a total of 10 doses (30 capsules). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care. Placebo Placebo Participants in this arm will receive oral placebo capsules (microcrystalline cellulose), 3 capsules daily from postoperative day (POD) 1 to POD 10, for a total of 10 doses (30 capsules). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.
- Primary Outcome Measures
Name Time Method Visual Analog Scale Pre-op and 2 week, 6 week, 12 week, 6 months, 1 year, 2 year post op The Visual Analog Scale (VAS) is a validated patient-reported outcome measure used to assess pain intensity. Patients rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain).
- Secondary Outcome Measures
Name Time Method Knee Range of Motion Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op Knee range of motion (ROM) will be assessed during visits using a goniometer to measure flexion and extension.
Quadriceps Strength Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op Quadriceps strength will be assessed using a dynamometer.
Isokinetic Strength 6 months, 9 months, 1-year post-op Isokinetic strength will be tested through biodex testing.
Time to Straight Leg Raise Up to 1 year Time to Straight Leg Raise (SLR) is defined as the number of days from surgery to the first postoperative day on which the patient can perform an active straight leg raise without an extensor lag.
Time to Return to Sport Up to 1 year Time to Return to Sport is defined as the number of days from surgery to the patient's clearance to resume full participation in sport-specific activities. Clearance is determined by the treating provider based on clinical evaluation, functional testing, and rehabilitation progress. This measure reflects overall recovery and readiness to return to pre-injury activity levels.
International Knee Documentation Committee Score Pre-op and 6 months, 1-year, 2-years post-op The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form is a validated, patient-reported outcome measure used to assess symptoms, function, and sports activity in individuals with knee disorders. Scores range from 0 to 100, with higher scores indicating better function and fewer symptoms.
Lysholm Knee Score Pre-op and 6 months, 1-year, 2-years post-op The Lysholm Knee Scoring Scale is a validated, patient-reported outcome measure used to assess knee function, symptoms, and stability following ligament injuries. Scores range from 0 to 100, with higher scores indicating better knee function.
Morphine Milligram Equivilants 2 weeks following surgery Morphine Milligram Equivalents (MMEs) will be used to quantify opioid consumption in the postoperative period (2 weeks post-op). All prescribed and consumed opioid medications will be converted to MMEs using standard CDC conversion factors. Total MMEs will be calculated for each participant over the initial postoperative period.
Trial Locations
- Locations (6)
Endeavor Health
🇺🇸Evanston, Illinois, United States
Washington University School of Medicine in St. Louis
🇺🇸Chesterfield, Missouri, United States
Duke University School of Medicine
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Campbell Clinic
🇺🇸Germantown, Tennessee, United States
Endeavor Health🇺🇸Evanston, Illinois, United StatesJoe Lamplot, MDPrincipal Investigator