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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 8-12 weeks, 12-16 weeks

Awards & highlights

SNAPU Trial Summary

This trial will study whether low-intensity pulsed ultrasound can decrease the time it takes for a scaphoid non-union to heal after surgery.

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.Check my eligibility

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.See study design

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.

SNAPU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-12 weeks, 12-16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-12 weeks, 12-16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-12 weeks, 12-16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to radiographic union as evidenced on serial CT scans

Secondary outcome measures

Functional outcomes as measured by range of motion and grip strength

Pattern of partial union on initial CT scan

Percentage of union

+2 more

SNAPU 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

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,000 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities at present to join this trial?

"Due to an update posted on May 16th 2022, clinicaltrials.gov currently lists this medical trial as inactive. In spite of its inactivity, there are 349 other trials actively recruiting participants at the moment."

Answered by AI

How many health care institutions are currently testing this experiment?

"The current enrolment process for this trial includes 6 different sites, with locations in Vancouver, Ottawa and Winnipeg among others. To keep the burden of travel to a minimum, it is important that potential participants choose the clinic closest to them if they decide to join."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Scaphoid Non-union and Low-intensity Pulsed Ultrasound Trial

Neil White 2014. "Scaphoid Non-union and Low-intensity Pulsed Ultrasound Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02383160.