3D Fracture Analysis Tool for Broken Leg

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool that uses 3D images to assist surgeons in planning surgeries for complex leg fractures. The 3D Fracture Analysis Tool aims to enhance surgical precision by illustrating various placements for screws and plates in broken bones, potentially reducing uncertainty and improving outcomes. It integrates seamlessly into current hospital routines without altering standard treatment. Individuals over 18 with a lower leg fracture may qualify for this study. As an unphased trial, this study offers participants the chance to contribute to innovative surgical planning techniques that could enhance future patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on evaluating a surgical planning tool without altering the standard of care, so you may not need to change your medications.

What prior data suggests that this 3D Fracture Analysis Tool is safe for use in surgical planning?

Research has shown that using 3D tools to examine bone fractures is generally safe for patients. Other studies have explored similar technologies that aid doctors in planning surgeries by creating 3D images of the bone. These studies found that these tools are usually well-tolerated, as they do not directly contact the body. Instead, they assist doctors in making more informed decisions before surgery. No evidence suggests harmful effects from using these tools for surgery planning, making it a low-risk option for those considering participation in a study involving the 3D Fracture Analysis Tool. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 3D Fracture Analysis Tool because it offers a cutting-edge approach to understanding and treating broken legs. Unlike traditional X-rays or CT scans, which provide only flat images, this tool creates detailed 3D models of fractures. This allows doctors to see the fracture from every angle, leading to more accurate assessments and personalized treatment plans. By improving the precision of fracture analysis, this tool has the potential to enhance recovery outcomes and reduce complications for patients.

What evidence suggests that this 3D fracture analysis tool is effective for broken legs?

Research has shown that using 3D technology in treating bone fractures can improve surgical outcomes. In this trial, participants will join the 3D Analysis Group, where the 3D Fracture Analysis Tool will be used. Studies have found that 3D models help doctors align broken bones more precisely, which is crucial for healing. Specifically, 3D images assist surgeons in planning the placement of screws and plates, enhancing the stability of the repaired bone. This method significantly reduces surgery time and improves procedural accuracy. Early evidence also suggests that these models can predict the effectiveness of different surgical methods, potentially making surgeries more predictable and successful. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with specific leg injuries: peroneal nerve injury, diaphyseal tibial fractures, or a broken leg. It's focused on those needing preoperative planning before screw and plate fixation surgery.

Inclusion Criteria

I am over 18 years old.

I have a broken bone in my leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Planning

Evaluation of a preoperative fracture analysis tool using 3D visualization and biomechanical modeling to assist in surgical planning

1 week

Surgery

Surgical procedure using the preoperative plan developed with the analysis tool

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery, including feedback on the tool's feasibility

1 week

What Are the Treatments Tested in This Trial?

Interventions

• 3D Fracture Analysis Tool

Trial Overview The study tests a new 3D Fracture Analysis Tool designed to help surgeons plan complex bone surgeries. Using patient CT scans, it simulates different surgical strategies to find the most stable fix without changing usual treatment.

How Is the Trial Designed?

Group I: 3D Analysis Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11391824/

Study on the efficacy of 3D printing technology combined with ... 3D printing technology combined with customized plates for complex tibial plateau fractures enables precise articular surface reduction, significantly shortens ...

2. withpower.com withpower.com/trial/phase-wounds-and-injuries-8-2025-8642a

3D Fracture Analysis Tool for Broken Leg This study aims to evaluate a preoperative fracture analysis tool that uses 3D visualization and biomechanical modeling to assist surgeons in planning screw ...

3. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2024.1383401/full

Treatment of complex limb fractures with 3D printing ... 3D printing technology can produce accurate physical models of fractures, and personalized custom plates can achieve better fracture realignment.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020138323001109

The value of digital 3D models in evaluating surgical ... The objective of the present study is to determine the value of digital 3D reconstruction models in the assessment of acetabular fracture reduction after ...

5. htworld.co.uk htworld.co.uk/news/3d-simulations-may-help-with-healing-of-broken-bones/

3D simulations may help with healing of broken bones Three-dimensional models could lead to deeper understanding of bone fracture nonunions and improvements in clinical treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11394268/

Artificial Intelligence-Based Applications for Bone Fracture ... This systematic review compiles and assesses existing research on AI applications aimed at identifying bone fractures through medical imaging

7. sciencedirect.com sciencedirect.com/science/article/pii/S0169260724003729

Very fast, high-resolution aggregation 3D detection CAM to ... This study introduces a novel weakly-supervised object localization approach for bone fracture detection in 3D facial images.

8. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-05051-w

Study on the efficacy of 3D printing technology combined ... 3D printing technology combined with customized plates for complex tibial plateau fractures enables precise articular surface reduction, significantly shortens ...