NCT06407180

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Teeradon Waewworawit · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Wrist Fractures
• Intraarticular Injection

Interventions

Type	Name	Description
DRUG	Triamcinolone Acetonide	receive intraarticular triamcinolone injection
DRUG	Normal saline	receive intraarticular normal saline injection

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-05-09
• Last updated: 2024-05-09