Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures

May 6, 2024 updated by: Teeradon Waewworawit

Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures: A Randomized Controlled Trial

The randomized controlled study which compare clinical outcomes (functional score) in patients with distal radius fractures who underwent open reduction with internal fixation and received intra-articular steroid injections to those who received placebo injections.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomization of Patients for Intra-articular Triamcinolone Injection

Objective: To compare the effectiveness of intra-articular Triamcinolone injection versus placebo in patients with distal radius fractures who underwent open reduction with internal fixation

Methods:

Patients: Patients with distal radius fractures who need open reduction with internal fixation procedure Randomization: Patients will be randomly assigned to one of two groups using a block randomization procedure with a block size of 4. Randomization will be performed using STATA version 16.0 software.

Interventions:

Group 1: Patients in this group will receive an intra-articular injection of 10 mg Triamcinolone (1 ml) during surgery.

Group 2: Patients in this group will receive an intra-articular injection of 1 ml normal saline solution during surgery.

Allocation Concealment:

A central randomization service will prepare sealed envelopes containing the assigned treatment for each patient.

The envelopes will be labeled with the patient's name and study ID. The envelopes will be kept in a secure location until the time of surgery.

Blinding:

The study participants, surgeons, and assessors will be blinded to the treatment allocation.

The syringes will be covered with an opaque glove material to further conceal the treatment allocation.

Outcome Measures:

Pain scores Function scores(PRWE score : Patient-Rated Wrist Evaluation) Wrist range of motion Grip strength

Follow-up:

Patients will be followed up at 2 weeks, 6 weeks, 3 months, and 6 months after surgery.

Statistical Analysis:

Demographic Analysis

Analyze the differences in each demographic factor between the groups. For continuous data, use Mean and Standard Deviation (S.D.). For categorical data, use Number, Percentage, and Chi-square. Inferential Statistics

Compare the results of the study, including:

Postoperative pain scores Wrist function score (PRWE) Wrist circumference (mm) Wrist grip strength (kg) Use Mean and S.D. for continuous data. Use Mixed linear model for data analysis. Use STATA 16.0 software for statistical calculations.

Study Type

Interventional

Enrollment (Estimated)

58

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 Contact

Study Contact Backup

  • Name: Thanat Charoenpol, Diploma of Orthopaedics
  • Phone Number: (+66)02-201-1589

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age more than 18 years old
  2. Closed unstable distal radius fracture unstable type which need surgical management
  3. Received procedure ORIF with plate and screws at injured wrist

Exclusion Criteria:

  1. History of corticosteroid allergy
  2. Poor Diabetes controlled (HbA1C) > 8
  3. Who need Ritonavir while enter this study
  4. Unable to follow up until the end of projects
  5. Unable to do questionnaires
  6. Infection around injured wrist
  7. Tear tendon at injured wrist
  8. Open fracture of injured wrist

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraarticular triamcinolone injection
receive Intraarticular triamcinolone injection
Drug: Triamcinolone Acetonide
receive intraarticular triamcinolone injection
Placebo Comparator: placebo group
receive Intraarticular normal saline injection
Drug: Normal saline
receive intraarticular normal saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Rated Wrist Evaluation Score
Time Frame: 12 months
(0-100) Higher scores mean poorer functional outcome
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale:
Time Frame: 12 months
(0-10) Higher scores mean more pain
12 months
Grip strength (kg)
Time Frame: 12 months
Measure by hand dynamometer
12 months
Wrist circumference
Time Frame: 12 months
12 months
ROM of wrist
Time Frame: 12 months
range of motion
12 months

Collaborators and Investigators

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

Sponsor

Teeradon Waewworawit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pending (Clinical Research Information Service)

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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