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

NCT06407180 | Not Yet Recruiting

• 1 other identifier: pending
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wrist Fractures; Intraarticular Injection

Keywords

Wrist Fractures; intraarticular injection; corticosteroids

Outcome Measures

Primary Outcomes (1)

• Patient-Rated Wrist Evaluation Score

  (0-100) Higher scores mean poorer functional outcome

  12 months

Secondary Outcomes (4)

• Visual Analog Scale:

  12 months

• Grip strength (kg)

  12 months

• Wrist circumference

  12 months

• ROM of wrist

  12 months

Study Arms (2)

Intraarticular triamcinolone injection

EXPERIMENTAL

receive Intraarticular triamcinolone injection

Drug: Triamcinolone Acetonide

placebo group

PLACEBO COMPARATOR

receive Intraarticular normal saline injection

Drug: Normal saline

Interventions

Triamcinolone Acetonide DRUG

receive intraarticular triamcinolone injection

Intraarticular triamcinolone injection

Normal saline DRUG

receive intraarticular normal saline injection

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teeradon Waewworawit: lead

Related Publications (8)

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16814787 RESULT

• 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.

  PMID: 32782009 RESULT

• 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.

  PMID: 26229158 RESULT

• 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 Mar 31.

  PMID: 32236715 RESULT

• 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.

  PMID: 31146626 RESULT

• 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.

  PMID: 21869712 RESULT

MeSH Terms

Conditions

Wrist Fractures

Interventions

Triamcinolone Acetonide; Saline Solution

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Teeradon Waewworawit, Doctor of medicine

CONTACT

(+66)928347744; teeradon.www@gmail.com

Thanat Charoenpol, Diploma of Orthopaedics

CONTACT

(+66)02-201-1589

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 9, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share