Arthroscopic Treatment Combine With TXA for Elbow Stiffness

November 18, 2021 updated by: Yi Lu, Beijing Jishuitan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Jishuitan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study group
Arthroscopic treatment with TXA injection
Drug: TXA
After the arthroscopic operation was completed, a local TXA injection was performed
PLACEBO_COMPARATOR: Control group
Arthroscopic treatment with normal saline injection
Drug: Saline
After the arthroscopic operation was completed, a local saline injection was performed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Jishuitan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2020

Primary Completion (ANTICIPATED)

December 30, 2022

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (ACTUAL)

December 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • YLu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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