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

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen ByNeil White, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

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.

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.

Participant Groups

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.

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.