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Scaphoid Non-union and Low-intensity Pulsed Ultrasound Trial

NCT02383160 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2022-05-18

No results posted yet for this study

Summary

This is a prospective, double-blind, multicentered, randomized controlled trial to determine the effectiveness of low-intensity pulsed ultrasound in decreasing the time to union of scaphoid non-unions after operative fixation as measured by serial CT scanning. Multiple centers across Canada will be involved in the study. Blinding will include patients, surgeons, research assistants, as well as all data handlers and analysts until trial completion or mid-term analysis.

Conditions

  • Nonunion of Fracture of Scaphoid Bone
  • Fractures, Ununited

Interventions

DEVICE

Bioventus Exogen 4000: Low-intensity pulsed ultrasound

Active low-intensity pulsed ultrasound

DEVICE

Sham device

Placebo device with no active therapy

Sponsors & Collaborators

  • Workers' Compensation Board, Alberta

    collaborator OTHER

  • Calgary Orthopaedic Research and Education Fund

    collaborator OTHER

  • Bioventus LLC

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Neil White, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02383160 on ClinicalTrials.gov