Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures
NCT ID: NCT06407180
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
58 participants
INTERVENTIONAL
2024-07-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures
NCT03898154
Distal Radius Steroid
NCT05655130
Randomized Controlled Trial Assessing the Effect of Dexamethasone on Postoperative Function After Distal Radius Fixation
NCT04889547
Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture
NCT04473989
Distal Radius Fracture - Treatment Comparison
NCT01883063
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intraarticular triamcinolone injection
receive Intraarticular triamcinolone injection
Triamcinolone Acetonide
receive intraarticular triamcinolone injection
placebo group
receive Intraarticular normal saline injection
Normal saline
receive intraarticular normal saline injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Triamcinolone Acetonide
receive intraarticular triamcinolone injection
Normal saline
receive intraarticular normal saline injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teeradon Waewworawit
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Teeradon Waewworawit
Doctor
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Thanat Charoenpol, Diploma of Orthopaedics
Role: CONTACT
References
Explore related publications, articles, or registry entries linked to this study.
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.
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
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
pending
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.