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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraarticular triamcinolone injection | Experimental | receive Intraarticular triamcinolone injection |
|
| placebo group | Placebo Comparator | receive Intraarticular normal saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide | Drug | receive intraarticular triamcinolone injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Rated Wrist Evaluation Score | (0-100) Higher scores mean poorer functional outcome | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale: | (0-10) Higher scores mean more pain | 12 months |
| Grip strength (kg) | Measure by hand dynamometer | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teeradon Waewworawit, Doctor of medicine | Contact | (+66)928347744 | teeradon.www@gmail.com | |
| Thanat Charoenpol, Diploma of Orthopaedics | Contact | (+66)02-201-1589 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 16814787 | Result | 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. | |
| 32782009 |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Normal saline | Drug | receive intraarticular normal saline injection |
|
| Wrist circumference | 12 months |
| ROM of wrist | range of motion | 12 months |
| 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. |
| 26229158 | 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. |
| 32236715 | 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. |
| 31146626 | 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. |
| 21869712 | 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |