Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407180
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-30
Brief Title:
Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures
Sponsor:
Teeradon Waewworawit
Organization:
Ramathibodi Hospital
Study Overview
Official Title:
Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 160 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 patients 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 scoresPRWE 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 SD 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 SD for continuous data Use Mixed linear model for data analysis Use STATA 160 software for statistical calculations
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 160 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 patients 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 scoresPRWE 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 SD 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 SD for continuous data Use Mixed linear model for data analysis Use STATA 160 software for statistical calculations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None