Arthroscopic Treatment Combine With TXA for Elbow Stiffness

NCT05138913 | Unknown

• 1 other identifier: YLu
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Tranexamic Acid; Elbow Stiffness

Outcome Measures

Primary Outcomes (1)

• Mayo Elbow Performance Score

  A score used to evaluated the elbow function

  baseline-6 months postoperatively

Secondary Outcomes (4)

• 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 Arms (2)

Study group

EXPERIMENTAL

Arthroscopic treatment with TXA injection

Drug: TXA

Control group

PLACEBO COMPARATOR

Arthroscopic treatment with normal saline injection

Drug: Saline

Interventions

TXA DRUG

After the arthroscopic operation was completed, a local TXA injection was performed

Study group

Saline DRUG

After the arthroscopic operation was completed, a local saline injection was performed

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yi Lu

  Sports Medicine Service, Beijing Jishuitan hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shangzhe Li, M.D.

CONTACT

+86 13826162999; 562744381@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sports Medicine Service of Beijing Jishuitan hospital

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: December 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)