Arthroscopic Treatment Combine With TXA for Elbow Stiffness

Tranexamic Acid Clinical Trial

Official title:

Prospective Randomized Controlled Study on Arthroscopic Treatment Combine With TXA for Elbow Stiffness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138913
• Other study ID #: YLu
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2021
• Source: Beijing Jishuitan Hospital
• Contact: Shangzhe Li, M.D.
• Phone: +86 13826162999
• Email: 562744381[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective randomized controlled study of different arthroscopic treatments for elbow stiffness combined with tranexamic acid(TXA) injection. The patients with stiffness were randomly divided into groups before the operation. After the arthroscopic operation was completed, they were divided into a local TXA injection group and a control group (normal saline) to perform additional operations for reduction of hemorrhage. In different time periods, the quantitative and qualitative indicators including pain, functional score, range of motion, level of Hemoglobin, the circumference of the limb 10cm above and below the elbow, amount of hemorrhage, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with TXA on the treatment of reduction of hemorrhage. Determine the effectiveness of TXA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Clinically diagnosed patients with elbow stiffness Young and middle-aged patients aged 18 to 60 with failed nonoperated treatment Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients No other comorbidities or medical diseases affect the surgical patients -

Exclusion Criteria:

Elderly people older than 60 years old and patients younger than 18 years old With severe comorbidities or medical diseases affect the surgical patients

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Related Conditions & MeSH terms

• Tranexamic Acid

Intervention

Drug:
• TXA
After the arthroscopic operation was completed, a local TXA injection was performed
• Saline
After the arthroscopic operation was completed, a local saline injection was performed

Locations

Country	Name	City	State
China	Beijing Jishuitan hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mayo Elbow Performance Score	A score used to evaluated the elbow function	baseline-6 months postoperatively
Secondary	Visual analogue scale	A score used to evaluated the pain	baseline-6 months postoperatively
Secondary	Circumference of upper extremity		baseline-6 months postoperatively
Secondary	change of hemoglobin		baseline-6 months postoperatively
Secondary	range of motion	flexion, extension, pronation and supination of elbow	baseline-6 months postoperatively