Intraarticular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction
Primary Purpose
Anterior Cruciate Ligament Reconstruction
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Tranexamic Acid Powder
Post-anterior cruciate ligament reconstruction (ACLR)
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Reconstruction focused on measuring Anterior cruciate ligament reconstruction, knee, hemarthrosis, tranexamic acid
Eligibility Criteria
Inclusion Criteria:
- patient agreed to participate in this study, signed an informed consent document.
- patients receiving arthroscopic ACLR with autologous hamstring grafts
Exclusion Criteria:
- previous knee procedures on the same side
- renal disorder or insufficiency
- abnormal coagulation profile
- refused to participate in this study
Sites / Locations
- Hsiao-Li
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid group
Control Group
Arm Description
Ten 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.
The control group patients only received ACLRs without TXA injections.
Outcomes
Primary Outcome Measures
The volume of drainage
hemoarthrosis
Secondary Outcome Measures
The grade of hemarthrosis
Grade I to IV.
The VAS was documented
scale 0 to 10.
IKDC functional score
Full Information
NCT ID
NCT03580018
First Posted
June 26, 2018
Last Updated
July 11, 2018
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03580018
Brief Title
Intraarticular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction
Official Title
Intraarticular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction - A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Reconstruction
Keywords
Anterior cruciate ligament reconstruction, knee, hemarthrosis, tranexamic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid group
Arm Type
Experimental
Arm Description
Ten 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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group patients only received ACLRs without TXA injections.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid Powder
Intervention Description
Ten mL of Tranexamic Acid(100 mg/mL) was injected into the joint at the end of the operation.
Intervention Type
Procedure
Intervention Name(s)
Post-anterior cruciate ligament reconstruction (ACLR)
Intervention Description
Post-anterior cruciate ligament reconstruction (ACLR)
Primary Outcome Measure Information:
Title
The volume of drainage
Description
hemoarthrosis
Time Frame
24 hours after surgery.
Secondary Outcome Measure Information:
Title
The grade of hemarthrosis
Description
Grade I to IV.
Time Frame
At day 3 and week 4.
Title
The VAS was documented
Description
scale 0 to 10.
Time Frame
Postoperative day 3 and week 4.
Title
IKDC functional score
Time Frame
Evaluated 4 weeks post-surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient agreed to participate in this study, signed an informed consent document.
patients receiving arthroscopic ACLR with autologous hamstring grafts
Exclusion Criteria:
previous knee procedures on the same side
renal disorder or insufficiency
abnormal coagulation profile
refused to participate in this study
Facility Information:
Facility Name
Hsiao-Li
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Intraarticular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction
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