Recruiting

Pansement Rigide Amovible

Sponsor:

Université de Sherbrooke

Code:

NCT03593174

Conditions

Trans-tibial Amputations

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Ossur Rigid Dressing

Elastic Bandage

Study Details

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).

Conditions

Trans-tibial Amputations

Study ID

NCT03593174

Start date

Nov 19, 2019

Status verified date

Sep, 2021

Completion date

Jun, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ossur Rigid Dressing

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

active comparator: Elastic bandage

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

Interventions

Ossur Rigid Dressing

Removable Rigid Dressing

Elastic Bandage

Usual modality: Elastic bandage

Primary outcome measure

  • Stump size [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Michel Tousignant, Phd

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

Locations

Université de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1K 2R1

More Information

Sponsor

Université de Sherbrooke

Last update posted

Sep 29, 2021

Last verified

Sep, 2021

Keywords

  • Amputation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2021-09-29.