Low-intensity Pulsed Ultrasound for Scaphoid Nonunion Fracture

(SNAPU Trial)

Not currently recruiting at 6 trial locations

Overseen By Sarah Reitzel, BN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Biologics

Disqualifiers: Rheumatologic disorder, Chronic renal failure, Pregnancy, others

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

Compensation: Varies

Number of Visits: 7

Duration: Up to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called Bioventus Exogen 4000, which uses low-intensity pulsed ultrasound, to determine if it can accelerate healing for individuals with a scaphoid nonunion fracture. Participants will be randomly assigned to either an active ultrasound treatment group or a sham (fake treatment) group, both used for 20 minutes daily until the fracture heals. This trial is ideal for those with a scaphoid fracture persisting for over three months, showing signs of improper healing, such as deformity or bone changes, and who can use the device for several months post-surgery. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for improved healing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are being treated for a rheumatologic disorder with a biologic medication, you would not be eligible to participate.

What prior data suggests that this low-intensity pulsed ultrasound device is safe for scaphoid nonunion fracture treatment?

Research has shown that low-intensity pulsed ultrasound (LIPUS), such as the Bioventus Exogen 4000, has been safely used for bone healing for over 25 years. Studies indicate that LIPUS is generally well-tolerated with few side effects. One study found that in cases where fractures didn't heal on their own, LIPUS helped about 85% of them heal.

The FDA has already approved the Exogen device for other types of bone healing, indicating it has passed strict safety tests. While this doesn't guarantee safety for everyone, it does offer some reassurance about its use in similar conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about low-intensity pulsed ultrasound (LIPUS) for treating scaphoid nonunion fractures because it offers a non-invasive approach to stimulate bone healing. Unlike traditional treatments like surgery or prolonged casting, LIPUS uses sound waves to enhance bone repair, potentially reducing recovery time and avoiding surgical risks. The Bioventus Exogen 4000 device delivers this ultrasound therapy daily for just 20 minutes, making it a convenient option for patients. This method could offer a faster, safer way to heal stubborn fractures that typically require more intensive intervention.

What evidence suggests that low-intensity pulsed ultrasound is effective for scaphoid nonunion fracture?

Research has shown that the Bioventus Exogen 4000 device, which uses gentle sound waves, effectively heals broken bones that don't heal on their own. Studies report that 86% of these difficult-to-heal fractures improved with this treatment, meaning most patients experienced bone healing. Other reports support this, showing a similar success rate of about 85%. In this trial, participants will receive either the active Bioventus Exogen 4000 device or a sham device. This sound wave treatment appears promising for helping bones like the scaphoid, which are often hard to heal, to join together successfully. ^{3 4 6 7 8}

Who Is on the Research Team?

Neil White, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject has a scaphoid fracture > 3 months-old with at least one feature of non-union including, collapse or humpback deformity, sclerosis at the fracture site or cystic changes evident on pre-operative diagnostic imaging

Subject has consented to surgical fixation at surgeon discretion

Subject is willing and has the ability to operate the LIPUS device for at least four to six months post-operatively

Exclusion Criteria

Subject with concomitant fracture or dislocation of another ipsilateral carpal bone, distal radius or ulna, or bilateral scaphoid fractures

Subject has an open or pathological fracture

Subject who are actively receiving treatment of a rheumatologic disorder with a biologic medication or other arthritic condition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either active or sham low-intensity pulsed ultrasound treatment for 20 minutes daily until fracture union is confirmed

Up to 6 months

Regular visits every 4-6 weeks for CT scans

Follow-up

Participants are monitored for functional outcomes and fracture union status

Up to 52 weeks

Follow-up visits at 2, 8, 12, 16, 24, 52, and 104 weeks

Long-term Follow-up

Participants with persistent non-unions continue follow-up until 1 year

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Bioventus Exogen 4000
• Sham device

Trial Overview 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.

How Is the Trial Designed?

Group I: Active LIPUS Unit Active Control 1 Intervention

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

Group II: Sham LIPUS Unit Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Workers' Compensation Board, Alberta

Collaborator

Trials

4

Recruited

710+

Calgary Orthopaedic Research and Education Fund

Collaborator

Trials

4

Recruited

530+

Bioventus LLC

Industry Sponsor

Trials

17

Recruited

15,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02383160

Scaphoid Non-union and Low-intensity Pulsed Ultrasound ... This is a prospective, double-blind, multicentered, randomized controlled trial to determine the effectiveness of low-intensity pulsed ultrasound in decreasing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9578507/

A Retrospective Study: Is Low-Intensity Pulsed Ultrasound ... Exogen (Bioventus, Durham, NC) is a well-known brand of LIPUS, and according to their data, they have an 86% healing rate for fracture non-union ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0020138321004277

Low-intensity pulsed ultrasound (LIPUS) for stimulation of ... Uncontrolled data from prospective case series suggest a positive effect of LIPUS in non united fractures with healing rates of around 85%.

4. withpower.com withpower.com/trial/phase-fractures-ununited-8-2014-c3315

Low-intensity Pulsed Ultrasound for Scaphoid Nonunion ... Research shows that low-intensity pulsed ultrasound (LIPUS), like the Bioventus Exogen 4000, can help heal bone fractures. In one study, 86% of patients with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4408126/

Low-Intensity Pulsed Ultrasound Treatment for Scaphoid ... Our study suggests that low-intensity pulsed ultrasound therapy can safely be utilized as an adjunctive modality in adolescents to augment scaphoid healing.

6. bioventus.com bioventus.com/wp-content/uploads/healthlink.pdf

Medical Policy LowIntensity Pulsed Ultrasound for Fracture Nonunion. In February ... data from a previous multicenter study on lowintensity pulsed ultrasound ...

7. medicalpolicy.bcbstx.com medicalpolicy.bcbstx.com/content/dam/bcbs/medicalpolicy/pdf/dme/DME101.030_2025-01-01.pdf

Low Intensity Pulsed Ultrasound Fracture Healing Device Exogen 4000+, now Exogen® Ultrasound Bone Healing System; Bioventus) was approved by the. U.S. Food and Drug Administration (FDA) through the ...

8. exogen.com exogen.com/en-gb/for-providers/

For Providers EXOGEN is a low-intensity pulsed ultrasound (LIPUS) bone stimulator with over 25 years of proven non-invasive bone healing.