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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06407180
Enrollment
58
Registered
2024-05-09
Start date
2024-07-01
Completion date
2026-12-31
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraarticular Injection, Wrist Fractures

Keywords

Wrist Fractures, intraarticular injection, corticosteroids

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.

Interventions

DRUGTriamcinolone Acetonide

receive intraarticular triamcinolone injection

DRUGNormal saline

receive intraarticular normal saline injection

Sponsors

Teeradon Waewworawit
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient-Rated Wrist Evaluation Score12 months(0-100) Higher scores mean poorer functional outcome

Secondary

MeasureTime frameDescription
Visual Analog Scale:12 months(0-10) Higher scores mean more pain
Grip strength (kg)12 monthsMeasure by hand dynamometer
Wrist circumference12 months
ROM of wrist12 monthsrange of motion

Contacts

Primary ContactTeeradon Waewworawit, Doctor of medicine
teeradon.www@gmail.com(+66)928347744
Backup ContactThanat Charoenpol, Diploma of Orthopaedics
(+66)02-201-1589

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026