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

Teeradon Waewworawit

Status: Not yet enrolling

Conditions: Intraarticular Injection; Wrist Fractures

Treatments: Drug: Normal saline; Drug: Triamcinolone Acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT06407180

pending (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups, including a placebo group

Intraarticular triamcinolone injection

Experimental group

Description:

receive Intraarticular triamcinolone injection

Treatment:

Drug: Triamcinolone Acetonide

placebo group

Placebo Comparator group

Description:

receive Intraarticular normal saline injection

Treatment:

Drug: Normal saline