NCT03593174

Brief Summary

The present study will measure the efficiency of a new modality for trans-tibial amputations in Quebec's health system, to reduce the time before prosthesis fitting, compared to the usual modality. The present study will evaluate the feasability of implantation of this new modality in Quebec and demonstrate its superiority in comparison to the usual modality (shorter time before fitting and reduction of costs).

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

June 19, 2018

Last Update Submit

September 27, 2021

Conditions

Trans-tibial Amputations

Keywords

Amputation

Outcome Measures

Primary Outcomes (1)

  • Stump size

    Leg circumference measure

    8 weeks

Study Arms (2)

Ossur Rigid Dressing

EXPERIMENTAL

Use of ORD, which is a type of Removable Rigid Dressing (RRD), as a post tibial amputation dressing modality.

Device: Ossur Rigid Dressing

Elastic bandage

ACTIVE COMPARATOR

Use of the elastic bandage as a post amputation dressing modality.

Device: Elastic Bandage

Interventions

Ossur Rigid DressingDEVICE

Removable Rigid Dressing

Ossur Rigid Dressing
Elastic BandageDEVICE

Usual modality: Elastic bandage

Elastic bandage

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Need of a trans-tibial amputation of atraumatic cause
  • Between 40 and 75 years of age

You may not qualify if:

  • \- Having a medical condition that could significantly affect the healing process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1K 2R1, Canada

RECRUITING

MeSH Terms

Interventions

Compression Bandages

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Michel Tousignant, Phd

    Université de Sherbrooke

    STUDY DIRECTOR

Central Study Contacts

Michel Tousignant, Phd

CONTACT

819-821-8000Michel.Tousignant@USherbrooke.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 19, 2018

Study Start

November 19, 2019

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)