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New treatment option for Distal Radius Fractures
Official title Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation
ClinicalTrials.gov ID: NCT06384456
What this study is testing
What is Topical TRanexamic Acid?
Topical TRanexamic Acid is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for distal radius fractures.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients undergoing open reduction internal fixation (Volar approach) for operative management of a distal radius fracture;
- Aged 18 or older;
- Provision of informed consent;
- Cognitive ability and English-language skills required to complete outcome measures.
You likely can't join if
- Revision surgery or any additional operative management of ipsilateral wrist injury
- Distal radius fracture treated with a dorsal approach
- Known history of lymphedema or lymph node dissection in the operative extremity
- Known chronic pain conditions, fibromyalgia, or polymyalgia rheumatic
- Current user of opioids and/or on chronic opioids use
- Known allergic reaction to TXA
See the full eligibility criteria
- Patients undergoing open reduction internal fixation (Volar approach) for operative management of a distal radius fracture;
- Aged 18 or older;
- Provision of informed consent;
- Cognitive ability and English-language skills required to complete outcome measures.
- Revision surgery or any additional operative management of ipsilateral wrist injury
- Distal radius fracture treated with a dorsal approach
- Known history of lymphedema or lymph node dissection in the operative extremity
- Known chronic pain conditions, fibromyalgia, or polymyalgia rheumatic
- Current user of opioids and/or on chronic opioids use
- Known allergic reaction to TXA
- Anticoagulant use not stopped in time for surgery as per thrombosis Canada guidelines (i.e. warfarin, acetylsalicylic acid, direct oral anticoagulants, etc.)
- Previous thrombotic stroke or thromboembolic disorders (i.e. known previous DVT, PE, or clotting disorders)
- Current pregnancy or breastfeeding
- Previous neurologic injury causing paralysis of affected shoulder/arm
- Severe cardio-respiratory disease (i.e. ASA Grade IV or higher).
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.