Arthroscopic Treatment Combine With TXA for Elbow Stiffness

Not Applicable

• Conditions: Tranexamic Acid; Elbow Stiffness
• Interventions: Drug: Saline; Drug: TXA

• Registration Number: NCT05138913
• Lead Sponsor: Beijing Jishuitan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-11-18
• Last Update Submitted: 2021-11-18
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline	Arthroscopic treatment with normal saline injection
Study group	TXA	Arthroscopic treatment with TXA injection

Primary Outcome Measures

Name	Time	Method
Mayo Elbow Performance Score	baseline-6 months postoperatively	A score used to evaluated the elbow function

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale	baseline-6 months postoperatively	A score used to evaluated the pain
Circumference of upper extremity	baseline-6 months postoperatively
change of hemoglobin	baseline-6 months postoperatively
range of motion	baseline-6 months postoperatively	flexion, extension, pronation and supination of elbow

Trial Locations

Locations (1)

Beijing Jishuitan hospital; 🇨🇳 Beijing, Beijing, China