Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

University Hospital, Angers

Status: Terminated

Conditions: Amputation; Adult Disease

Treatments: Other: Socket without Revofit system; Other: Socket with Revofit system

Study type: Interventional

Funder types: Other

Identifiers

NCT04276714

49RC19_0129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Adjustable socket

Experimental group

Description:

First week of the study is with adjustable socket

Treatment:

Other: Socket with Revofit system

Other: Socket without Revofit system

Classical socket

Experimental group

Description:

First week of the study is with classical socket

Treatment:

Other: Socket with Revofit system

Other: Socket without Revofit system