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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 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.

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.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
811 Previous Clinical Trials
892,661 Total Patients Enrolled
Workers' Compensation Board, AlbertaOTHER
3 Previous Clinical Trials
555 Total Patients Enrolled
Calgary Orthopaedic Research and Education FundOTHER
3 Previous Clinical Trials
376 Total Patients Enrolled
Bioventus LLCIndustry Sponsor
16 Previous Clinical Trials
15,077 Total Patients Enrolled
Neil White, MDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
550 Total Patients Enrolled

Media Library

Bioventus Exogen 4000 (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02383160 — N/A
Scaphoid Nonunion Fracture Research Study Groups: Sham LIPUS Unit, Active LIPUS Unit
Scaphoid Nonunion Fracture Clinical Trial 2023: Bioventus Exogen 4000 Highlights & Side Effects. Trial Name: NCT02383160 — N/A
Bioventus Exogen 4000 (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02383160 — N/A
~14 spots leftby Dec 2025
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