Arthroscopic Treatment Combine With TXA for Elbow Stiffness

Study Overview
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Brief Summary
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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.

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

Conditions
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Tranexamic Acid, Elbow Stiffness

Intervention / Treatment
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* Drug: TXA
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Arthroscopic treatment with TXA injection | Drug: TXA<br>* After the arthroscopic operation was completed, a local TXA injection was performed<br>|
| Placebo Comparator: Control group<br>Arthroscopic treatment with normal saline injection | Drug: Saline<br>* After the arthroscopic operation was completed, a local saline injection was performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mayo Elbow Performance Score | A score used to evaluated the elbow function | baseline-6 months postoperatively | 

Secondary Outcome Measures

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