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Procedure
Bridge Plate Timing for Wrist Fractures (TORPEDO Trial)
N/A
Recruiting
Led By Ali Azad, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or greater
Fracture of the distal radius indicated for operative treatment using bridge plate fixation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up removal of bridge plate (from week 6 to up to week 14), week 104
Awards & highlights
TORPEDO Trial Summary
This trial will compare wrist function/range of motion after 6-8 weeks vs. 12+ weeks of bridge plate fixation for distal radius fractures. 100 patients will be studied.
Who is the study for?
This trial is for adults over 18 with a specific type of wrist fracture (distal radius fracture) that requires surgery using bridge plate fixation. It's not for those who need revision surgery, have fractures due to disease, can't follow up properly, or have fractures on both wrists.Check my eligibility
What is being tested?
The study is testing if removing the bridge plate used in wrist fracture surgeries after just 6-8 weeks has the same results as waiting more than 12 weeks. Participants are randomly placed into two groups: one gets early removal and the other follows standard timing.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of surgery, limited range of motion in the wrist during recovery, and risks associated with surgical procedures such as infection or delayed healing.
TORPEDO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I need surgery for a broken wrist using a specific method.
Select...
I understand and can agree to the study's procedures and risks.
TORPEDO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ removal of bridge plate (from week 6 to up to week 14), week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~removal of bridge plate (from week 6 to up to week 14), week 104
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hand
Secondary outcome measures
Wrist
Change in Radial Height
Change in Radial Inclination
+9 moreTORPEDO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bridge Plate Removal at 6-8 Weeks PostoperativelyExperimental Treatment2 Interventions
Participants will undergo dorsal spanning bridge plate fixation per standard technique. Patients in the experimental group will return to the operative room for removal of the bridge plate at Week 6-8. Patients will begin the standardized postoperative rehabilitation protocol immediately following bridge plate removal on Week 6-8.
Group II: Bridge Plate Removal at 12-14 Weeks PostoperativelyActive Control2 Interventions
Participants will undergo dorsal spanning bridge plate fixation per standard technique. Patients in the control group will return to the operating room for removal of the bridge plate at Week 12-14. Patients will begin the standardized postoperative rehabilitation protocol immediately following bridge plate removal on Week 12-14.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,363 Previous Clinical Trials
816,386 Total Patients Enrolled
Ali Azad, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had a fracture caused by a medical condition.I had surgery to fix bones that didn't heal right using a bridge plate.I understand and can agree to the study's procedures and risks.I need surgery for a broken wrist using a specific method.I have fractures in both wrists.
Research Study Groups:
This trial has the following groups:- Group 1: Bridge Plate Removal at 6-8 Weeks Postoperatively
- Group 2: Bridge Plate Removal at 12-14 Weeks Postoperatively
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it currently possible to participate in this experiment?
"Affirmative. According to data on clinicaltrials.gov, this research endeavour commenced on February 1st 2023 and is actively seeking participants with the goal of recruiting 100 individuals at one medical facility."
Answered by AI
How extensive is the participation in this clinical research endeavor?
"Affirmative, the trial is still open for participants. According to clinicaltrials.gov, it was posted on February 1st 2023 and last modified on February 14th 2023 - with a target of 100 volunteers from one site."
Answered by AI
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