NCT02383160

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

8.3 years

First QC Date

February 26, 2015

Last Update Submit

May 16, 2022

Conditions

Nonunion of Fracture of Scaphoid BoneFractures, Ununited

Keywords

Low-intensity pulsed ultrasoundNonunionScaphoidOperative

Outcome Measures

Primary Outcomes (1)

  • Time to radiographic union as evidenced on serial CT scans

    up to 52 weeks

Secondary Outcomes (6)

  • Percentage of union

    8 weeks post-op

  • Percentage of union

    12 weeks post-op

  • Rate of change of percent union

    8-12 weeks, 12-16 weeks

  • Pattern of partial union on initial CT scan

    8 weeks

  • Time to return to work

    up to 52 weeks

  • +1 more secondary outcomes

Study Arms (2)

Active LIPUS Unit

ACTIVE COMPARATOR

Low-intensity pulsed ultrasound treatment 20 minutes/day until the fracture is deemed united clinically and on CT scan.

Device: Bioventus Exogen 4000: Low-intensity pulsed ultrasound

Sham LIPUS Unit

SHAM COMPARATOR

Sham device treatment 20 minutes/day until the fracture is deemed united clinically and on CT scan.

Device: Sham device

Interventions

Bioventus Exogen 4000: Low-intensity pulsed ultrasoundDEVICE

Active low-intensity pulsed ultrasound

Also known as: Bioventus Exogen 4000
Active LIPUS Unit
Sham deviceDEVICE

Placebo device with no active therapy

Also known as: Bioventus Exogen 4000 Sham Unit
Sham LIPUS Unit

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a scaphoid fracture \> 3 months-old with at least one feature of non-union including, collapse or humpback deformity, sclerosis at the fracture site or cystic changes evident on pre-operative diagnostic imaging
  • Subject has consented to surgical fixation at surgeon discretion
  • Subject is willing and has the ability to operate the LIPUS device for at least four to six months post-operatively

You may not qualify if:

  • Subject with concomitant fracture or dislocation of another ipsilateral carpal bone, distal radius or ulna, or bilateral scaphoid fractures
  • Subject has an open or pathological fracture
  • Subject who are actively receiving treatment of a rheumatologic disorder with a biologic medication or other arthritic condition
  • Subject has a history of fibrous dysplasia, chronic renal failure, Paget's disease, osteopetrosis or other impairing disease/condition of the musculoskeletal system
  • Subject with an active infection of the affected limb
  • Subject with a high risk of death within the follow up period
  • Subject is a prisoner or at high risk of incarceration
  • Subject who are unlikely to complete follow-up (no fixed address, states they are unlikely to complete follow up, psychiatric condition at surgeon discretion)
  • Subject has cognitive impairment or language difficulties that would impede the completion of questionnaires
  • Subject who are pregnant or anticipate getting pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

South Health Campus

Calgary, Alberta, T3M1M4, Canada

Location

Peter Lougheed Centre

Calgary, Alberta, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

PanAM Clinic Foundation

Winnipeg, Manitoba, Canada

Location

The Ottawa Hospital (Civic Campus)

Ottawa, Ontario, Canada

Location

Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Neil White, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor, Section of Orthopaedics, Hand & Wrist Surgeon

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 9, 2015

Study Start

September 1, 2014

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

CA(6)