Intraarticular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction
1 other identifier
interventional
320
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedFirst Submitted
Initial submission to the registry
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 9, 2018
CompletedJuly 12, 2018
July 1, 2018
12 months
June 26, 2018
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The volume of drainage
hemoarthrosis
24 hours after surgery.
Secondary Outcomes (3)
The grade of hemarthrosis
At day 3 and week 4.
The VAS was documented
Postoperative day 3 and week 4.
IKDC functional score
Evaluated 4 weeks post-surgery.
Study Arms (2)
Tranexamic Acid group
EXPERIMENTALTen 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.
Control Group
PLACEBO COMPARATORThe control group patients only received ACLRs without TXA injections.
Interventions
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)
Eligibility Criteria
You may qualify if:
- patient agreed to participate in this study, signed an informed consent document.
- patients receiving arthroscopic ACLR with autologous hamstring grafts
You may not qualify if:
- previous knee procedures on the same side
- renal disorder or insufficiency
- abnormal coagulation profile
- refused to participate in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hsiao-Li
Taipei, 11217, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2018
First Posted
July 9, 2018
Study Start
June 1, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
July 12, 2018
Record last verified: 2018-07