What side effects are associated with this type of intervention?

Low-Intensity Pulsed Ultrasound (LIPUS) is generally well-tolerated with minimal side effects, primarily involving mild skin irritation at the application site. Surgical fixation, another common treatment for scaphoid nonunion fractures, can have side effects including infection, hardware irritation, and nonunion or delayed union of the bone. Bone grafting, often used in conjunction with surgical fixation, may lead to donor site pain, infection, and graft failure. Overall, while LIPUS is less invasive with fewer side effects, surgical options carry more significant risks.

What prior FDA approvals exist?

The FDA has approved several treatments for bone healing and fracture management, including Low-Intensity Pulsed Ultrasound (LIPUS) devices. LIPUS, such as the Exogen system, is specifically approved for the treatment of nonunion fractures, including scaphoid nonunion fractures. These devices work by promoting bone healing through the stimulation of cellular activity and increased blood flow to the fracture site. Other related treatments include bone grafting and internal fixation, but LIPUS remains a non-invasive option that has shown efficacy in enhancing fracture healing.

What other types of research exist?

Promising novel alternatives to Low-Intensity Pulsed Ultrasound (LIPUS) for scaphoid nonunion fractures include: 1) Platelet-Rich Plasma (PRP) therapy, which uses concentrated platelets to promote healing and tissue regeneration. 2) Stem cell therapy, which involves the use of mesenchymal stem cells to enhance bone repair and regeneration. 3) Extracorporeal Shock Wave Therapy (ESWT), which uses shock waves to stimulate bone healing and increase blood flow. These therapies are being explored for their potential to improve outcomes in bone healing and may be considered in consultation with a healthcare provider.

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Ultrasound Therapy

Low-intensity Pulsed Ultrasound for Scaphoid Nonunion Fracture (SNAPU Trial)

N/A

Waitlist Available

Led By Neil White, MD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 52 weeks

Summary

This trial is testing a device that uses gentle sound waves to help wrist bones heal faster. It targets patients with a specific type of wrist fracture that hasn't healed properly. The sound waves from the device stimulate bone cells to grow and repair the fracture more quickly.

Who is the study for?

This trial is for individuals with a scaphoid fracture older than 3 months showing non-union signs, who have agreed to surgical fixation. Participants must be able to use the LIPUS device post-surgery for 4-6 months. It's not for those with additional fractures in the same arm, certain bone diseases, active infections or conditions that could impair follow-up.

What is being tested?

The study tests if low-intensity pulsed ultrasound (LIPUS) can speed up bone healing after surgery in patients with non-healing scaphoid bones. Patients are randomly assigned to receive either LIPUS or a sham device without knowing which one they get.

What are the potential side effects?

While specific side effects of LIPUS aren't detailed here, similar devices typically have minimal risks which may include mild discomfort at the site of application.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Functional outcomes as measured by range of motion and grip strength

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active LIPUS UnitActive Control1 Intervention

Low-intensity pulsed ultrasound treatment 20 minutes/day until the fracture is deemed united clinically and on CT scan.

Group II: Sham LIPUS UnitPlacebo Group1 Intervention

Sham device treatment 20 minutes/day until the fracture is deemed united clinically and on CT scan.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Scaphoid Nonunion Fracture include surgical fixation, bone grafting, and Low-Intensity Pulsed Ultrasound (LIPUS). Surgical fixation involves stabilizing the fracture with screws or pins to promote proper alignment and healing. Bone grafting adds new bone tissue to the fracture site, which helps bridge the gap and stimulate bone regeneration. LIPUS promotes bone healing by stimulating cellular activity and increasing blood flow to the fracture site, which accelerates the healing process. These mechanisms are crucial for patients as they address the challenges of poor blood supply and delayed healing associated with scaphoid fractures, ultimately improving recovery outcomes.