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Bridge Plate Timing for Wrist Fractures

(TORPEDO Trial)

MT
AA
Overseen ByAli Azad, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this randomized control trial will be to determine whether the duration of bridge plate fixation of distal radius fractures can be reduced to 6-8 weeks without worsening of functional outcomes relative to the current standard of greater than 12 weeks of fixation. The secondary aim of the study is to determine whether a reduced duration of bridge plate fixation leads to an increase in wrist range of motion following plate removal compared to the standard duration of fixation. 100 patients with comminuted distal radius fractures that are indicated for bridge plate fixation will be randomized to the Accelerated Removal arm (n = 50) or the Standard Removal arm (n = 50).

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What safety data exists for bridge plate timing in wrist fractures?

The provided research does not contain specific safety data for bridge plate timing in wrist fractures or related techniques like Dorsal Spanning Bridge Plate Fixation. The studies focus on antithrombotic therapy and bridging strategies in cardiac and surgical contexts, which are not directly applicable to wrist fracture treatments.12345

Is Dorsal Spanning Bridge Plate Fixation a promising treatment for wrist fractures?

Yes, Dorsal Spanning Bridge Plate Fixation is a promising treatment for wrist fractures. It helps stabilize the wrist, allowing for weight-bearing and rehabilitation, especially in complex cases. Studies show it provides good outcomes similar to other methods, making it a valuable option for treating wrist fractures.678910

What data supports the idea that Bridge Plate Timing for Wrist Fractures is an effective treatment?

The available research shows that Bridge Plate Timing for Wrist Fractures, also known as dorsal bridge plating, is an effective treatment option. One study compared it to external fixation and found that both methods led to good, similar outcomes in terms of function and appearance of the wrist after healing. However, infections were more common with external fixators, while some nerve-related issues were more frequent with bridge plates. Another study highlighted that bridge plates are particularly useful for patients with multiple injuries, as they allow for early movement and weight-bearing, which is important for recovery. Overall, the choice between treatments depends on the specific injury and patient needs, but bridge plates are a reliable option.6791011

Who Is on the Research Team?

AA

Ali Azad, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I understand and can agree to the study's procedures and risks.
I need surgery for a broken wrist using a specific method.

Exclusion Criteria

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.
Patients that will be unable to complete the necessary follow up, including incarcerated patients
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dorsal spanning bridge plate fixation and are randomized to either accelerated or standard removal of the bridge plate

6-14 weeks
Regular visits for monitoring and rehabilitation

Follow-up

Participants are monitored for safety and effectiveness after bridge plate removal, including assessments of wrist function and range of motion

Up to 104 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dorsal Spanning Bridge Plate Fixation
  • Dorsal Spanning Bridge Plate Removal
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Bridge Plate Removal at 6-8 Weeks PostoperativelyExperimental Treatment2 Interventions
Group II: Bridge Plate Removal at 12-14 Weeks PostoperativelyActive Control2 Interventions

Dorsal Spanning Bridge Plate Fixation is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Dorsal Spanning Bridge Plate Fixation for:
🇪🇺
Approved in European Union as Dorsal Bridge Plating for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

Dorsal bridge plating (DBP) is primarily used for treating comminuted intra-articular distal radius fractures, with a median follow-up of 24 months showing an overall complication rate of 13%.
Patients demonstrated moderate functional outcomes with a mean wrist range of motion and DASH scores indicating some level of disability, suggesting that while DBP is effective, there are notable risks and patient-reported challenges post-surgery.
Dorsal Bridge Plate for Distal Radius Fractures: A Systematic Review.Fares, AB., Childs, BR., Polmear, MM., et al.[2021]
In a study of 45 patients with comminuted distal radius fractures, both external fixators and dorsal bridge plates resulted in similar functional and radiological outcomes one year post-surgery.
While infections were more common in patients treated with external fixators, they exhibited better residual grip strength, whereas those with dorsal bridge plates experienced more cases of reflex sympathetic neuropathy.
Analysis of the Clinical and Radiological Results of Bridge Plate Versus External Fixation in Comminuted Distal Radius Fractures.Carula, BC., Pereira, MDS., Ferreira, APB., et al.[2023]
In a study of 50 patients with distal radius fractures, the radiographic outcomes of bridge plate fixation to the second metacarpal were found to be similar to those fixed to the third metacarpal, indicating flexibility in surgical approach based on individual patient anatomy.
Radiographic measurements such as radial height, inclination, and tilt showed little to no loss of alignment over time, suggesting that both fixation methods are effective in maintaining fracture stability post-surgery.
Evaluation of Radiographic Parameters Following Dorsal Wrist-Spanning Plate Fixation of Distal Radius Fractures to the Second Versus Third Metacarpal.Bradley, H., Rodriguez, J., Ahn, J., et al.[2023]

Citations

Dorsal Bridge Plate for Distal Radius Fractures: A Systematic Review. [2021]
Analysis of the Clinical and Radiological Results of Bridge Plate Versus External Fixation in Comminuted Distal Radius Fractures. [2023]
Evaluation of Radiographic Parameters Following Dorsal Wrist-Spanning Plate Fixation of Distal Radius Fractures to the Second Versus Third Metacarpal. [2023]
Dorsal spanning plate fixation for distal radius fractures. [2013]
Supplementary Fixation Improves Stability of Intra-Articular Distal Radius Fractures Managed With a Spanning Plate. [2023]
Sellar and parasellar tumor removal without discontinuing antithrombotic therapy. [2018]
Efficacy and safety of tirofiban bridge as an alternative to suspension of dual antiplatelet therapy in patients undergoing surgery: a systematic review. [2021]
Bridge therapy or standard treatment for urgent surgery after coronary stent implantation: Analysis of 314 patients. [2018]
Cangrelor in patients undergoing cardiac surgery: the BRIDGE study. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Stent-Related Adverse Events as Related to Dual Antiplatelet Therapy in First- vs Second-Generation Drug-Eluting Stents. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Bridge Plate Failure with Extensor Tendon Injury: A Case Report and Literature Review. [2022]
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