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

Wrist Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06407180
• Other study ID #: pending
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Ramathibodi Hospital
• Contact: Teeradon Waewworawit, Doctor of medicine
• Phone: (+66)928347744
• Email: teeradon.www[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Intraarticular Injection
• Radius Fractures
• Wrist Fractures

Intervention

Drug:
• Triamcinolone Acetonide
receive intraarticular triamcinolone injection
• Normal saline
receive intraarticular normal saline injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teeradon Waewworawit

References & Publications (8)

Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30. — View Citation

Habib GS, Miari W. The effect of intra-articular triamcinolone preparations on blood glucose levels in diabetic patients: a controlled study. J Clin Rheumatol. 2011 Sep;17(6):302-5. doi: 10.1097/RHU.0b013e31822acd7c. — View Citation

Kim YS, Lee KG, Lee HJ. Effect of triamcinolone acetonide on stiffness after surgical treatment of proximal humerus fractures: a randomized controlled study. Arch Orthop Trauma Surg. 2020 Nov;140(11):1731-1737. doi: 10.1007/s00402-020-03425-3. Epub 2020 M — View Citation

Kong L, Zhai Y, Zhang Z, Lu J, Zhang B, Tian D. Radiocarpal joint stiffness following surgical treatment for distal radius fractures: the incidence and associated factors. J Orthop Surg Res. 2020 Aug 11;15(1):313. doi: 10.1186/s13018-020-01857-6. — View Citation

Laohaprasitiporn P, Monteerarat Y, Jaderojananont W, Limthongthang R, Vathana T. Validity, Reliability and Responsiveness of the Thai Version of Patient-Rated Wrist Evaluation (Th-PRWE) in Distal Radius Fracture Patients. Siriraj Med J [Internet]. 2021 Mar. 9 [cited 2024 Feb. 15];73(4):275-81. Available from: https://he02.tci-thaijo.org/index.php/sirirajmedj/article/view/246833

Mittal A, Bhuti G, Dondeti U, akhtar u, pathak d. CORTICOSTEROID INJECTION AT THE FRACTURE SITE AS AN EFFECTIVE METHOD OF PAIN RELIEF IN SINGLE RIB FRACTURES: A PROSPECTIVE STUDY 2021.

Petersen SK, Hansen I, Andreasen RA. Low frequency of septic arthritis after arthrocentesis and intra-articular glucocorticoid injection. Scand J Rheumatol. 2019 Sep;48(5):393-397. doi: 10.1080/03009742.2019.1584329. Epub 2019 May 31. — View Citation

Saied A, Heshmati A, Sadeghifar A, Mousavi AA, Arabnejad F, Pooladsanj A. Prophylactic corticosteroid injection in ulnar wrist pain in distal radius fracture. Indian J Orthop. 2015 Jul-Aug;49(4):393-7. doi: 10.4103/0019-5413.159595. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Rated Wrist Evaluation Score	(0-100) Higher scores mean poorer functional outcome	12 months
Secondary	Visual Analog Scale:	(0-10) Higher scores mean more pain	12 months
Secondary	Grip strength (kg)	Measure by hand dynamometer	12 months
Secondary	Wrist circumference		12 months
Secondary	ROM of wrist	range of motion	12 months