Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

Not Applicable

Terminated

• Conditions: Amputation; Adult Disease
• Interventions: Other: Socket without Revofit system; Other: Socket with Revofit system

• Registration Number: NCT04276714
• Lead Sponsor: University Hospital, Angers

Brief 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. 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 Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Study Start: 2021-02-22
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Classical socket	Socket without Revofit system	First week of the study is with classical socket
Adjustable socket	Socket without Revofit system	First week of the study is with adjustable socket
Adjustable socket	Socket with Revofit system	First week of the study is with adjustable socket
Classical socket	Socket with Revofit system	First week of the study is with classical socket

Primary Outcome Measures

Name	Time	Method
Pain change assessment	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 \[VAS : 0 to 10 which constitues the worst outcome\].

Secondary Outcome Measures

Name	Time	Method
Functional effects in twin task	Once a week during four weeks	A walking analysis by GAITrite once a week
Functional effects in simple task	Once a week during four weeks	A walking analysis by a six-minute walking distance test once a week
Everyday comfort	four weeks	Quality of life assessed by daily number of adaptation of the prosthesis
Patient satisfaction with assistive technology	Once a week during four weeks	Assessment of patient satisfaction by using Quebec User Evaluation of Satisfaction with assistive Technology \[QUEST\] survey

Trial Locations

Locations (1)

DIMONAIS; 🇫🇷 Angers, France