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

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 3 4 5 11}

Research Team

Ali Azad, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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 am 18 years old or older.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dorsal Bridge Plate for Distal Radius Fractures: A Systematic Review. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Analysis of the Clinical and Radiological Results of Bridge Plate Versus External Fixation in Comminuted Distal Radius Fractures. [2023]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Dorsal spanning plate fixation for distal radius fractures. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Supplementary Fixation Improves Stability of Intra-Articular Distal Radius Fractures Managed With a Spanning Plate. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Sellar and parasellar tumor removal without discontinuing antithrombotic therapy. [2018]

7. Brazil 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Bridge therapy or standard treatment for urgent surgery after coronary stent implantation: Analysis of 314 patients. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Cangrelor in patients undergoing cardiac surgery: the BRIDGE study. [2013]

10. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Bridge Plate Failure with Extensor Tendon Injury: A Case Report and Literature Review. [2022]