Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale

Study Overview
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Brief Summary
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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).

Detailed Description
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The main objective of the present study is to obtain an estimation of the efficiency of a Removable Rigid Dressing (RRD) -type compression modality immediately following a tibial amputation as an alternative to the elastic bandage, which is the usually-used modality. This pilot study will verify the feasability of implantation of this type of dressing, and to collect data on the main dependant variables of this research projet in order to eventually estimate the expected effect on a larger population. The main objectives of this study are: To explore the efficacy of the RRD in comparison to the elastic bandage on the size of the stump, associated complications and necessary time to fitting of the prosthesis. Verify the facilitators and obstacles to implantation of the RRD as a post tibial ambutation dressing modality as an alternative to the elastic bandage.

Official Title
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Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale

Conditions
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Trans-tibial Amputations

Intervention / Treatment
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* Device: Ossur Rigid Dressing
* Device: Elastic Bandage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ossur Rigid Dressing<br>Use of ORD, which is a type of Removable Rigid Dressing (RRD), as a post tibial amputation dressing modality. | Device: Ossur Rigid Dressing<br>* Removable Rigid Dressing<br>|
| Active Comparator: Elastic bandage<br>Use of the elastic bandage as a post amputation dressing modality. | Device: Elastic Bandage<br>* Usual modality: Elastic bandage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stump size | Leg circumference measure | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation