Bridge Plate Timing for Wrist Fractures

(TORPEDO Trial)

Overseen By Ali Azad, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Revision surgery, Bilateral fractures, Pathologic fractures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether people with wrist fractures can have their bridge plates removed sooner—at 6-8 weeks instead of the usual 12 weeks—without affecting wrist function. The study also examines whether earlier plate removal can enhance wrist movement after removal. It involves two groups: one with plates removed at 6-8 weeks and another at 12-14 weeks. This trial targets individuals with a specific type of wrist fracture requiring a bridge plate, a type of internal fixator used in surgery. As an unphased trial, it offers participants the chance to contribute to research that could improve recovery times for future patients.

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 prior data suggests that this bridge plate fixation technique is safe for wrist fractures?

Research has shown that using a special plate to fix wrist fractures is safe. This method typically results in good recovery and is well-received by patients. Most individuals experience few problems. However, a small risk exists that the plate could wear out over time, potentially harming nearby tendons. Although these cases are rare, awareness is important. Overall, this treatment is considered effective and safe for most people with complex wrist fractures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring the optimal timing for removing a bridge plate used in wrist fracture repairs. Unlike current methods, which might not precisely define when to take out the hardware, this study is testing two specific timeframes—6-8 weeks and 12-14 weeks post-surgery. By comparing these two approaches, researchers hope to find out which timing leads to the best recovery and quickest return to normal activities. This could potentially refine postoperative care and improve outcomes for patients with wrist fractures.

What evidence suggests that this trial's treatments could be effective for wrist fractures?

Research has shown that a dorsal spanning bridge plate is a safe and effective treatment for complex wrist fractures, particularly those near the wrist. In this trial, participants will undergo dorsal spanning bridge plate fixation, with one group having the plate removed at 6-8 weeks postoperatively and another group at 12-14 weeks postoperatively. Studies have found that this treatment generally results in good wrist function after healing. Compared to other methods like external fixation, bridge plating often provides better stability and healing. However, some reports mention a slight decrease in wrist mobility. Overall, this treatment is considered a strong option, especially for more severe wrist fractures. ^{1 2 6 7 8}

Who Is on the Research Team?

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

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?

Group I: Bridge Plate Removal at 6-8 Weeks Postoperatively Experimental Treatment 2 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 Postoperatively Active Control 2 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.

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:

• Comminuted distal radius fractures
• High-energy distal radius fractures
• Polytrauma patients

Approved in European Union as Dorsal Bridge Plating for:

• Complex distal radius fractures
• Axially shortened fractures
• Chronic fractures

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study of 30 patients undergoing transsphenoidal surgery for sellar and parasellar tumors, those who continued antithrombotic therapy showed no significant difference in intraoperative bleeding or operation time compared to those who discontinued therapy.

The results suggest that it may not be necessary to stop antithrombotic treatment before this type of surgery, as all patients had successful outcomes without neurological deficits, indicating a potential for safer surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sellar and parasellar tumor removal without discontinuing antithrombotic therapy. Ogawa, Y., Tominaga, T.[2018]

In a study of 314 patients undergoing non-emergency surgery after coronary stenting, intravenous tirofiban as a bridge therapy significantly reduced the rate of Net Adverse Clinical Events (NACE) to 8% compared to 22.5% in the control group, indicating its efficacy in improving patient outcomes.

The bridge therapy was especially effective when surgery occurred within 60 days of stenting, with an odds ratio of 0.09 for NACE, and there were no cases of stent thrombosis in the bridge group, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridge therapy or standard treatment for urgent surgery after coronary stent implantation: Analysis of 314 patients. De Servi, S., Morici, N., Boschetti, E., et al.[2018]

The BRIDGE trial demonstrated that cangrelor is both effective and safe for patients on long-term dual antiplatelet therapy (DAPT) who require coronary artery bypass graft surgery, addressing the need for a temporary antiplatelet solution during surgical procedures.

This study highlights the importance of cangrelor in managing patients at high risk for thromboembolic events, suggesting its potential for broader applications in non-coronary artery bypass graft surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cangrelor in patients undergoing cardiac surgery: the BRIDGE study. Voeltz, MD., Manoukian, SV.[2013]

A case report of a 26-year-old woman highlighted serious complications from dorsal spanning plate fixation for a distal radius fracture, including plate breakage and significant damage to the extensor pollicis longus tendon.

This case underscores the risks associated with spanning plate fixation, particularly the potential for complications like metallosis and tendon injury, which can complicate subsequent surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridge Plate Failure with Extensor Tendon Injury: A Case Report and Literature Review. Lefebvre, R., Intravia, J., Cao, L., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 15,009 patients, second-generation drug-eluting stents (G2-DES) showed significantly lower rates of stent thrombosis (0.7% vs 1.4%) and target vessel revascularization (16.2% vs 22.1%) compared to first-generation stents (G1-DES) over a 5-year period.

Long-term dual antiplatelet therapy (DAPT) beyond one year reduced the risk of very late stent thrombosis for G1-DES, but this benefit was not observed for G2-DES, indicating that G2-DES may be safer in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stent-Related Adverse Events as Related to Dual Antiplatelet Therapy in First- vs Second-Generation Drug-Eluting Stents. Yoshikawa, Y., Shiomi, H., Morimoto, T., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The tirofiban bridge technique, used as an alternative to withdrawing dual antiplatelet therapy before surgery, shows promise in reducing adverse cardiac events in patients who have undergone stenting within the last 12 months, based on a systematic review of 422 patients across five studies.

The use of tirofiban does not appear to increase the risk of bleeding or hemorrhagic events, suggesting it is a safe option; however, more randomized clinical trials are necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirofiban bridge as an alternative to suspension of dual antiplatelet therapy in patients undergoing surgery: a systematic review. Riscado, LVS., de Pinho, JHS., Lobato, AC.[2021]

In a study involving 30 cadaveric forearms, supplementary fixation with a dorsal bridge plate significantly reduced displacement of intra-articular wrist fractures under weight-bearing conditions compared to using the bridge plate alone.

The results indicated that using additional fixation methods, such as k-wires or a radial pin plate, allowed for safer early weight-bearing, as these methods showed less displacement and failure under cyclic loading compared to the non-fixation group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementary Fixation Improves Stability of Intra-Articular Distal Radius Fractures Managed With a Spanning Plate. Modest, JM., Raducha, JE., Schilkowsky, RM., et al.[2023]

Dorsal spanning plate fixation is an effective surgical option for managing multifragmentary distal radius fractures in polytrauma patients, facilitating early mobilization and rehabilitation.

The technique allows for definitive fixation of the fracture while enabling weight-bearing through the injured wrist, which is crucial for recovery in these complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal spanning plate fixation for distal radius fractures. Dodds, SD., Save, AV., Yacob, A.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11483764/

Distal Radius Fracture Outcomes After Dorsal Spanning ... Dorsal spanning plate fixation provides a safe and effective method for treating complex distal radius fractures. In our series, patients had good functional ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7113002/

Dorsal Bridge Plating versus External Fixation for Distal ... Bridge plating and external fixation both appear to be comparable for spanning fixation constructs for distal radius fractures, but with bridge plating having ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0363502324006427

Clinical and Radiographic Outcomes of Distal Radius ... Dorsal bridge plating (DBP) can effectively treat complex distal radius fractures (DRFs); however, techniques for metacarpal fixation vary. The ...

4. link.springer.com link.springer.com/article/10.1007/s12306-024-00822-4

dorsal bridge plating in distal radius fractures DBP is a good alternative to volar plating for complex distal radius fractures. The functional outcomes showed a slight loss of range of movement.

5. journals.lww.com journals.lww.com/jorthotrauma/fulltext/2021/09003/distal_radius_fractures_and_the_dorsal_spanning.3.aspx

Distal Radius Fractures and the Dorsal Spanning Plate in... The dorsal spanning plate is an excellent option in the treatment of high-energy fractures and patients with polytrauma, fractures with dorsal or volar ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0363502315005778

Functional Outcomes Following Bridge Plate Fixation for ... Distraction bridge plate fixation for distal radius fractures is safe with minimal complications. Functional outcomes are similar to those published for other ...

7. researchgate.net researchgate.net/publication/370195252_Distal_Radius_Fracture_Outcomes_After_Dorsal_Spanning_Plate_Fixation

Distal Radius Fracture Outcomes After Dorsal Spanning ... Conclusions: Dorsal spanning plate fixation provides a safe and effective method for treating complex distal radius fractures. In our series, ...

8. surgicoll.scholasticahq.com surgicoll.scholasticahq.com/article/68060-fatigue-failure-of-a-distal-radius-dorsal-spanning-locked-bridge-plate-with-tendon-rupture-a-case-report-and-a-review-of-the-literature

Fatigue Failure of a Distal Radius Dorsal Spanning ... Low-profile bridge plates in distal radius fractures can result in early fatigue failure and tendon injury. Stouter plates and/or low-profile ...