Trans-tibial AmputationsNCT03593174
Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale
A study testing Ossur Rigid Dressing and Elastic Bandage in people with Trans-tibial Amputations, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Trans-tibial Amputations
- What is being tested?
- Ossur Rigid Dressing and Elastic Bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 19 Nov 2019to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need of a trans-tibial amputation of atraumatic cause
- Between 40 and 75 years of age
Who cannot join
- Having a medical condition that could significantly affect the healing process
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Université de Sherbrooke
Sherbrooke, Quebec, J1K 2R1
Michel Tousignant, PhD
About this study
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).
Read the detailed description
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.
- Conditions
- Trans-tibial Amputations
- Being tested
- Ossur Rigid Dressing, Elastic Bandage
- Keywords
- Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ossur Rigid DressingDevice
Removable Rigid Dressing
Elastic BandageDevice
Usual modality: Elastic bandage
| Study group | Role | What they receive |
|---|---|---|
| Ossur Rigid Dressing | Experimental | Use of ORD, which is a type of Removable Rigid Dressing (RRD), as a post tibial amputation dressing modality. Receives: Device: Ossur Rigid Dressing |
| Elastic bandage | Active comparator | Use of the elastic bandage as a post amputation dressing modality. Receives: Device: Elastic Bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stump size
Leg circumference measure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start19 Nov 2019
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trans-tibial AmputationsStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Tousignant, Phd, Study director, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593174
- Sponsor's protocol ID
- 2018-2617
- Status last verified
- Sep 2021
- First submitted
- 19 Jun 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale
- ClinicalTrials.gov ID
- NCT03593174
- Acronym / sponsor ID
- 2018-2617
- Conditions
- Trans-tibial Amputations
- Keywords
- Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ossur Rigid Dressing | Experimental | Device: Ossur Rigid DressingUse of ORD, which is a type of Removable Rigid Dressing (RRD), as a post tibial amputation dressing modality. |
| Elastic bandage | Active comparator | Device: Elastic BandageUse of the elastic bandage as a post amputation dressing modality. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Need of a trans-tibial amputation of atraumatic cause
- Between 40 and 75 years of age
Key exclusion criteria (1 listed)
- Having a medical condition that could significantly affect the healing process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ossur Rigid DressingRemovable Rigid Dressing | Device | Ossur Rigid Dressing |
| Elastic BandageUsual modality: Elastic bandage | Device | Elastic bandage |
Primary outcome
Stump size
Time frame: 8 weeks
Leg circumference measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Trans-tibial Amputations
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
Active, not recruitingObservational study
Kinematics of Ewing Amputees
Lower Extremity Amputation, Trans-Tibial Amputation
Recruiting
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Amputation of Lower Limb, Prosthesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Tousignant, Phd study director
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ossur Rigid Dressing and Elastic Bandage in people with Trans-tibial Amputations, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Tousignant, Phd (819-821-8000 ext. 72900, Michel.Tousignant@USherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stump size (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.