Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures
- Conditions
- Wrist FracturesIntraarticular Injection
- Interventions
- Drug: Normal saline
- Registration Number
- NCT06407180
- Lead Sponsor
- Teeradon Waewworawit
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 58
- Age more than 18 years old
- Closed unstable distal radius fracture unstable type which need surgical management
- Received procedure ORIF with plate and screws at injured wrist
- History of corticosteroid allergy
- Poor Diabetes controlled (HbA1C) > 8
- Who need Ritonavir while enter this study
- Unable to follow up until the end of projects
- Unable to do questionnaires
- Infection around injured wrist
- Tear tendon at injured wrist
- Open fracture of injured wrist
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Normal saline receive Intraarticular normal saline injection Intraarticular triamcinolone injection Triamcinolone Acetonide receive Intraarticular triamcinolone injection
- Primary Outcome Measures
Name Time Method Patient-Rated Wrist Evaluation Score 12 months (0-100) Higher scores mean poorer functional outcome
- Secondary Outcome Measures
Name Time Method Grip strength (kg) 12 months Measure by hand dynamometer
ROM of wrist 12 months range of motion
Visual Analog Scale: 12 months (0-10) Higher scores mean more pain
Wrist circumference 12 months