Low-intensity Pulsed Ultrasound for Scaphoid Nonunion Fracture

(SNAPU Trial)

Recruiting at 5 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

154 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Bioventus Exogen 4000 for scaphoid nonunion fractures?

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 bone healing issues improved with this treatment, and another study found that 93% of adolescents with scaphoid nonunion healed after using LIPUS following surgery. ^{1 2 3 4 5}

Is low-intensity pulsed ultrasound safe for treating scaphoid nonunion fractures?

Low-intensity pulsed ultrasound has been used safely in humans for treating scaphoid nonunion fractures, with studies reporting no significant complications. In one study, 93% of adolescent patients healed without surgical or postoperative complications, although one patient developed extra bone growth around the scaphoid. ^{1 2 3 4 5}

How does the treatment Bioventus Exogen 4000 differ from other treatments for scaphoid nonunion fractures?

Bioventus Exogen 4000 uses low-intensity pulsed ultrasound (LIPUS) to stimulate bone healing, which is different from the standard surgical approach. This non-invasive treatment involves daily 20-minute sessions and has shown promise in improving healing rates without the need for additional surgery. ^{1 2 3 4 5}

Research Team

Neil White, MD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Low-intensity pulsed ultrasound for treating delayed union scaphoid fractures: case series. [2018]

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

[Is low intensity ultrasound effective in treatment of disorders of fracture healing?]. [2019]

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

Low-intensity pulsed ultrasound treatment for scaphoid fracture nonunions in adolescents. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Does low intensity, pulsed ultrasound speed healing of scaphoid fractures?]. [2016]

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

Low-intensity pulsed ultrasound in the treatment of traumatic hand fracture in an elite athlete. [2019]