Active LIPUS Unit for Fractures, Ununited

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fractures, Ununited+2 More
Bioventus Exogen 4000: Low-intensity pulsed ultrasound - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Fractures, Ununited
  • Nonunion of Fracture of Scaphoid Bone

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 8-12 weeks, 12-16 weeks

12 weeks post-op
Percentage of union
8 weeks
Pattern of partial union on initial CT scan
8-12 weeks, 12-16 weeks
Rate of change of percent union
up to 52 weeks
Functional outcomes as measured by range of motion and grip strength
Time to radiographic union as evidenced on serial CT scans
Time to return to work

Trial Safety

Trial Design

2 Treatment Groups

Active LIPUS Unit
1 of 2
Sham LIPUS Unit
1 of 2
Active Control
Non-Treatment Group

154 Total Participants · 2 Treatment Groups

Primary Treatment: Active LIPUS Unit · Has Placebo Group · N/A

Sham LIPUS Unit
Device
ShamComparator Group · 1 Intervention: Sham device · Intervention Types: Device
Active LIPUS Unit
Device
ActiveComparator Group · 1 Intervention: Bioventus Exogen 4000: Low-intensity pulsed ultrasound · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8-12 weeks, 12-16 weeks

Who is running the clinical trial?

University of CalgaryLead Sponsor
701 Previous Clinical Trials
492,737 Total Patients Enrolled
Workers' Compensation Board, AlbertaOTHER
3 Previous Clinical Trials
555 Total Patients Enrolled
Bioventus LLCIndustry Sponsor
15 Previous Clinical Trials
15,064 Total Patients Enrolled
1 Trials studying Fractures, Ununited
12,387 Patients Enrolled for Fractures, Ununited
Calgary Orthopaedic Research and Education FundOTHER
3 Previous Clinical Trials
376 Total Patients Enrolled
Neil White, MDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
550 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subject has a scaphoid fracture that is more than three months old and has at least one feature of non-union, including a collapse or humpback deformity, sclerosis at the fracture site, or cystic changes evident on pre-operative diagnostic imaging.
The subject is willing and able to use the ultrasound device for four to six months after surgery.
The subject has agreed to allow the surgeon to fix the problem as they see fit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: October 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.