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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03580018
Other study ID # 2017-07-004B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date May 31, 2018

Study information

Verified date July 2018
Source Taipei Veterans General Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tranexamic Acid Powder
Ten mL of Tranexamic Acid(100 mg/mL) was injected into the joint at the end of the operation.
Procedure:
Post-anterior cruciate ligament reconstruction (ACLR)
Post-anterior cruciate ligament reconstruction (ACLR)

Locations

Country Name City State
Taiwan Hsiao-Li Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The volume of drainage hemoarthrosis 24 hours after surgery.
Secondary The grade of hemarthrosis Grade I to IV. At day 3 and week 4.
Secondary The VAS was documented scale 0 to 10. Postoperative day 3 and week 4.
Secondary IKDC functional score Evaluated 4 weeks post-surgery.
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