Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2021-03-10

Brief Summary

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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.

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Detailed Description

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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

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Amputation Adult Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single Case Experimental Design : multiple N of 1 trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adjustable socket

First week of the study is with adjustable socket

Group Type EXPERIMENTAL

Socket without Revofit system

Intervention Type OTHER

All the tests are evaluate during one week with the classical type of fittings

Socket with Revofit system

Intervention Type OTHER

All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)

Classical socket

First week of the study is with classical socket

Group Type EXPERIMENTAL

Socket without Revofit system

Intervention Type OTHER

All the tests are evaluate during one week with the classical type of fittings

Socket with Revofit system

Intervention Type OTHER

All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)

Interventions

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Socket without Revofit system

All the tests are evaluate during one week with the classical type of fittings

Intervention Type OTHER

Socket with Revofit system

All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No