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Anterior Cruciate Ligament ReconstructionNCT03580018

Intraarticular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction

A study testing Tranexamic Acid Powder and Post-anterior cruciate ligament reconstruction (ACLR) in people with Anterior Cruciate Ligament Reconstruction, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Post-anterior cruciate ligament reconstruction (ACLR) hemarthrosis may result in increased pain thus delaying postoperative rehabilitation, which may eventually lead to arthrofibrosis and a functional deficit. Read more about this study

Who is it for?
Ages 20 to 60 years
What is being tested?
Tranexamic Acid Powder and Post-anterior cruciate ligament reconstruction (ACLR)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
1 siteTaiwan
Study dates
1 Jun 2017to 31 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • patient agreed to participate in this study, signed an informed consent document.
  • patients receiving arthroscopic ACLR with autologous hamstring grafts

Who cannot join

  • previous knee procedures on the same side
  • renal disorder or insufficiency
  • abnormal coagulation profile
  • refused to participate in this study

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Hsiao-Li

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: Intraarticular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction - A Prospective Randomized Study

Post-anterior cruciate ligament reconstruction (ACLR) hemarthrosis may result in increased pain thus delaying postoperative rehabilitation, which may eventually lead to arthrofibrosis and a functional deficit. Many antifibrinolytic agents, including tranexamic acid (TXA), have been used in orthopedic surgeries to reduce postoperative bleeding.The purpose of this study is to evaluate the effect of intra-articular injection of TXA in patients receiving arthroscopic ACLRs. Patients were randomized into two groups. Group 1 patients (TXA group) received the index procedures with a 10 mL intra-articular injection of TXA. Group 2 (control group) patients received the index procedures without TXA injections. An intra-articular suction drain was placed recorded 24 h postoperatively. Clinical evaluations using an IKDC functional score, range of motion (ROM), and a Visual Analogue Scale (VAS) pain score were performed at postoperative day 3 and week 4.

Read the detailed description

TXA group patients received ACLRs and a 10 mL intra-articular injection of TXA after the procedure. The control group patients only received ACLRs without TXA injections. Randomization was done on the day of the surgery, by an independent investigator who did not participate in the surgery, using the permuted block randomization technique.

The same surgeon treated all patients enrolled in this study. Spinal anesthesia was given to all patients and a pneumatic tourniquet was routinely used. In brief, through a 3 cm incision over the medial proximal tibia, semitendinosus (ST) and gracilis (Gr) tendons were harvested from the distal insertion. Tendons were quadrupled and whip stitched by No. 2 and No. 5 Ethibond sutures (Ethicon, Somerville, NJ). The diameters of the folded tendons were determined by using sizing cylinders with incremental size changes of 0.5 mm.The femoral sockets were created at about the 1:30 position (left knee), through the anteromedial portal. The tibial tunnel was created with an ACUFEX guide (Smith \& Nephew, Andover, MA). The diameters of the socket were created in the same manner as the diameter of the folded graft. At tibial site, grafts were fixed with bioscrews (BIORCI-HA, Smith \& Nephew) at 30 degrees of knee flexion. The screw and the tunnel sizes were the same. After completion of the procedure, a suction drain (Zimmer HEMOVAC, Warsaw, IN) was placed at the superior lateral aspect of the joint. Ten mL of TXA (100 mg/mL) (Daiichi Sankyo, Tokyo, Japan) was injected into the joint at the end of the operation and the drain was clamped for 2 h.

Clinical evaluations The volume of drainage was recorded 24 h after surgery. The grade of hemarthrosis, as previously described by Coupens et al.,was also documented at day 3 and week The range of knee motion and the IKDC functional score were evaluated 4 weeks post-surgery. The VAS was documented at postoperative day 3 and week 4.

Statistical analysis. All data are expressed as a mean and standard deviation (SD). The amount of drainage or functional scores between different groups were compared with an independent t test.

All statistical analyses were conducted using SPSS version 11.0 (SPSS Inc., Chicago,IL). Differences were considered significant when the p-value was < 0.05.

Being tested
Tranexamic Acid Powder, Post-anterior cruciate ligament reconstruction (ACLR)
Keywords
Anterior cruciate ligament reconstruction, knee, hemarthrosis, tranexamic acid
Medical subject headings
Hemarthrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic Acid PowderDrug

    Ten mL of Tranexamic Acid(100 mg/mL) was injected into the joint at the end of the operation.

  • Post-anterior cruciate ligament reconstruction (ACLR)Procedure or surgery

    Post-anterior cruciate ligament reconstruction (ACLR)

Study groups in NCT03580018
Study groupRoleWhat they receive
Tranexamic Acid groupExperimentalTen mL of TXA (100 mg/mL) was injected into the joint at the end of the index operation and the drain was clamped for 2 h.
Receives: Drug: Tranexamic Acid Powder
Control GroupPlacebo comparatorThe control group patients only received ACLRs without TXA injections.
Receives: Procedure: Post-anterior cruciate ligament reconstruction (ACLR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The volume of drainage

    hemoarthrosis

    Measured: 24 hours after surgery.

Secondary outcomes (3)
  1. The grade of hemarthrosis

    Grade I to IV.

    Measured: At day 3 and week 4.

  2. The VAS was documented

    scale 0 to 10.

    Measured: Postoperative day 3 and week 4.

  3. IKDC functional score

    Measured: Evaluated 4 weeks post-surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2018
  2. Study start1 Jun 2017
  3. Primary completion31 May 2018
  4. Study completion31 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03580018
Sponsor's protocol ID
2017-07-004B
Status last verified
Jul 2018
First submitted
26 Jun 2018
Last updated
12 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Tranexamic Acid Powder and Post-anterior cruciate ligament reconstruction (ACLR) in people with Anterior Cruciate Ligament Reconstruction, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The volume of drainage (time frame: 24 hours after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.

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