Wrist FracturesNCT06407180
Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures
A study testing Triamcinolone Acetonide and Normal saline in people with Wrist Fractures and Intraarticular Injection, run by Teeradon Waewworawit.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrist Fractures, Intraarticular Injection
- What is being tested?
- Triamcinolone Acetonide and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Thanat Charoenpol, Diploma of Orthopaedics contact
About this study
Official title: Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures: A Randomized Controlled Trial
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.
Read the 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 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
- Wrist Fractures, Intraarticular Injection
- Being tested
- Triamcinolone Acetonide, Normal saline
- Keywords
- Wrist Fractures, intraarticular injection, corticosteroids
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
receive intraarticular triamcinolone injection
Normal salineDrug
receive intraarticular normal saline injection
| Study group | Role | What they receive |
|---|---|---|
| Intraarticular triamcinolone injection | Experimental | receive Intraarticular triamcinolone injection Receives: Drug: Triamcinolone Acetonide |
| placebo group | Placebo comparator | receive Intraarticular normal saline injection Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Wrist Evaluation Score
(0-100) Higher scores mean poorer functional outcome
Measured: 12 months
Secondary outcomes (4)
Visual Analog Scale:
(0-10) Higher scores mean more pain
Measured: 12 months
Grip strength (kg)
Measure by hand dynamometer
Measured: 12 months
Wrist circumference
Measured: 12 months
ROM of wrist
range of motion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Wrist FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teeradon Waewworawit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Teeradon Waewworawit, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407180
- Sponsor's protocol ID
- pending
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16814787Kong 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.
PubMed 32782009Saied 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.
PubMed 26229158Kim 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.
PubMed 32236715Petersen 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.
PubMed 31146626Habib 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.
PubMed 21869712
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06407180
- Acronym / sponsor ID
- pending
- Conditions
- Wrist Fractures, Intraarticular Injection
- Keywords
- Wrist Fractures, intraarticular injection, corticosteroids
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Teeradon WaewworawitUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraarticular triamcinolone injection | Experimental | Drug: Triamcinolone Acetonidereceive Intraarticular triamcinolone injection |
| placebo group | Placebo comparator | Drug: Normal salinereceive Intraarticular normal saline injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone Acetonidereceive intraarticular triamcinolone injection | Drug | Intraarticular triamcinolone injection |
| Normal salinereceive intraarticular normal saline injection | Drug | placebo group |
Primary outcome
Patient-Rated Wrist Evaluation Score
Time frame: 12 months
(0-100) Higher scores mean poorer functional outcome
4 secondary outcomes
Visual Analog Scale:
Time frame: 12 months
Grip strength (kg)
Time frame: 12 months
Wrist circumference
Time frame: 12 months
ROM of wrist
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- BackgroundMittal 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.
- BackgroundLaohaprasitiporn 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
- Results publication: PubMed 16814787Court-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.
- Results publication: PubMed 32782009Kong 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.
- Results publication: PubMed 26229158Saied 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.
- Results publication: PubMed 32236715Kim 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.
- Results publication: PubMed 31146626Petersen 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.
- Results publication: PubMed 21869712Habib 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thanat Charoenpol, Diploma of Orthopaedics contact
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide and Normal saline in people with Wrist Fractures and Intraarticular Injection, run by Teeradon Waewworawit.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teeradon Waewworawit, Doctor of medicine ((+66)928347744, teeradon.www@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated Wrist Evaluation Score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407180, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.