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Clinical Trials/NCT05138913
NCT05138913
Unknown
Not Applicable

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

Beijing Jishuitan Hospital1 site in 1 country80 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
TXA
Conditions
Tranexamic Acid
Sponsor
Beijing Jishuitan Hospital
Enrollment
80
Locations
1
Primary Endpoint
Mayo Elbow Performance Score
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
December 30, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yi Lu

Director of Sports Medicine Service of Beijing Jishuitan hospital

Beijing Jishuitan Hospital

Eligibility Criteria

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

Arms & Interventions

Study group

Arthroscopic treatment with TXA injection

Intervention: TXA

Control group

Arthroscopic treatment with normal saline injection

Intervention: Saline

Outcomes

Primary Outcomes

Mayo Elbow Performance Score

Time Frame: baseline-6 months postoperatively

A score used to evaluated the elbow function

Secondary Outcomes

  • Visual analogue scale(baseline-6 months postoperatively)
  • Circumference of upper extremity(baseline-6 months postoperatively)
  • change of hemoglobin(baseline-6 months postoperatively)
  • range of motion(baseline-6 months postoperatively)

Study Sites (1)

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