AmputationNCT04276714
Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients
A study testing Socket without Revofit system and Socket with Revofit system in people with Amputation and Adult Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volume of residual limb is constant from 12 to 18 months after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Adult Disease
- What is being tested?
- Socket without Revofit system and Socket with Revofit system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2021to 10 Mar 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years old and above
- Above knee or below knee amputation (irrespective of etiology and time from amputation)
- Residual limb pain
- Prosthetic with classic fitting
- Fluctuations of residual limb requiring prosthetic adaptation (stump cotton sock, wedgning fitting …)
- Recipients or registered with a social security scheme
- Informed consent form signed beforehand
Who cannot join
- Patient with peripheral neuropathies contraindicating the use of Revofit system
- Pregnant woman, nursing mother or parturiant
- Patient in detention by judicial or administrative decision
- Patient undergoing psychiatric compulsory care
- Patient in a health or social institution for purposes other than research
- Legally protected person
- Patient unable to express their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Revofit™ System and Residual Limb Pain in Amputee Patients : Multiple N-of-1 Trial
At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volume of residual limb is constant from 12 to 18 months after surgery. However, some daily fluctuations could appear due to an underlying vascular disease for example, which could be painful and impact the quality of life with a constant need of prosthetics adjustment. The goal of this study is to assess the effectiveness of a system-adjusted fitting in comparison with a standard fitting.
Read the detailed description
With the " multiple N-of-1 trial " study type, pain, quality of life, functional effects and the patient satisfaction with assistive technology will be assessed for four weeks.
- Conditions
- Amputation, Adult Disease
- Being tested
- Socket without Revofit system, Socket with Revofit system
- Keywords
- residual limbs, pain, adjustable socket
- Medical subject headings
- Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket without Revofit systemOther
All the tests are evaluate during one week with the classical type of fittings
Socket with Revofit systemOther
All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)
| Study group | Role | What they receive |
|---|---|---|
| Adjustable socket | Experimental | First week of the study is with adjustable socket Receives: Other: Socket without Revofit system; Other: Socket with Revofit system |
| Classical socket | Experimental | First week of the study is with classical socket Receives: Other: Socket without Revofit system; Other: Socket with Revofit system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain change assessment
Assess the impact of the Revofit™ system adjusted-fitting on residual limb pain compared to a classic fitting with a daily Visual Analog Scale evaluation [VAS : 0 to 10 which constitues the worst outcome].
Measured: four weeks
Secondary outcomes (4)
Everyday comfort
Quality of life assessed by daily number of adaptation of the prosthesis
Measured: four weeks
Functional effects in twin task
A walking analysis by GAITrite once a week
Measured: Once a week during four weeks
Functional effects in simple task
A walking analysis by a six-minute walking distance test once a week
Measured: Once a week during four weeks
Patient satisfaction with assistive technology
Assessment of patient satisfaction by using Quebec User Evaluation of Satisfaction with assistive Technology [QUEST] survey
Measured: Once a week during four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start22 Feb 2021
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Why it stopped: Not enough patients (difficulty in recruiting according to the inclusion criteria)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Crossover
- Model description
- Single Case Experimental Design : multiple N of 1 trial
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mickaël Dinomais, Principal investigator, MD University hospital AngersYoann RONZI, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276714
- Sponsor's protocol ID
- 49RC19_0129
- Status last verified
- Jul 2022
- First submitted
- 7 Feb 2020
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revofit™ System and Residual Limb Pain in Amputee Patients : Multiple N-of-1 Trial
- ClinicalTrials.gov ID
- NCT04276714
- Acronym / sponsor ID
- 49RC19_0129
- Conditions
- Amputation, Adult Disease
- Keywords
- residual limbs, pain, adjustable socket
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients (difficulty in recruiting according to the inclusion criteria)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 19 Feb 2020 (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.
At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volume of residual limb is constant from 12 to 18 months after surgery. However, some daily fluctuations could appear due to an underlying vascular disease for example, which could be painful and impact the quality of life with a constant need of prosthetics adjustment. The goal of this study is to assess the effectiveness of a system-adjusted fitting in comparison with a standard fitting.
Detailed description
With the " multiple N-of-1 trial " study type, pain, quality of life, functional effects and the patient satisfaction with assistive technology will be assessed for four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single Case Experimental Design : multiple N of 1 trial
| Arm | Type | Receives |
|---|---|---|
| Adjustable socket | Experimental | Other: Socket without Revofit system, Other: Socket with Revofit systemFirst week of the study is with adjustable socket |
| Classical socket | Experimental | Other: Socket without Revofit system, Other: Socket with Revofit systemFirst week of the study is with classical socket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 years old and above
- Above knee or below knee amputation (irrespective of etiology and time from amputation)
- Residual limb pain
- Prosthetic with classic fitting
- Fluctuations of residual limb requiring prosthetic adaptation (stump cotton sock, wedgning fitting …)
Key exclusion criteria (7 listed)
- Patient with peripheral neuropathies contraindicating the use of Revofit system
- Pregnant woman, nursing mother or parturiant
- Patient in detention by judicial or administrative decision
- Patient undergoing psychiatric compulsory care
- Patient in a health or social institution for purposes other than research
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 |
|---|---|---|
| Socket without Revofit systemAll the tests are evaluate during one week with the classical type of fittings | Other | Adjustable socket, Classical socket |
| Socket with Revofit systemAll the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system) | Other | Adjustable socket, Classical socket |
Primary outcome
Pain change assessment
Time frame: four weeks
Assess the impact of the Revofit™ system adjusted-fitting on residual limb pain compared to a classic fitting with a daily Visual Analog Scale evaluation [VAS : 0 to 10 which constitues the worst outcome].
4 secondary outcomes
Everyday comfort
Time frame: four weeks
Functional effects in twin task
Time frame: Once a week during four weeks
Functional effects in simple task
Time frame: Once a week during four weeks
Patient satisfaction with assistive technology
Time frame: Once a week during four weeks
Results and safety
The study was stopped early (reason given: Not enough patients (difficulty in recruiting according to the inclusion criteria)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Mickaël Dinomais principal investigator
MD University hospital Angers
Yoann RONZI principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket without Revofit system and Socket with Revofit system in people with Amputation and Adult Disease, run by University Hospital, Angers at 1 site in France.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Jul 2022. 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 France. 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?
The study was stopped early (reason given: Not enough patients (difficulty in recruiting according to the inclusion criteria)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain change assessment (time frame: four 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 6 Jul 2022.