Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

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.

Study Overview

• Status: Terminated
• Conditions: Amputation; Adult Disease
• Intervention / Treatment: Other: Socket without Revofit system; Other: Socket with Revofit system

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • DIMONAIS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjustable socket; First week of the study is with adjustable socket	Other: Socket without Revofit system; All the tests are evaluate during one week with the classical type of fittings; 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)
Experimental: Classical socket; First week of the study is with classical socket	Other: Socket without Revofit system; All the tests are evaluate during one week with the classical type of fittings; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Everyday comfort	Quality of life assessed by daily number of adaptation of the prosthesis	four weeks
Functional effects in twin task	A walking analysis by GAITrite once a week	Once a week during four weeks
Functional effects in simple task	A walking analysis by a six-minute walking distance test once a week	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	Once a week during four weeks

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Mickaël Dinomais, MD University hospital Angers; Principal Investigator: Yoann RONZI, MD

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): March 10, 2021
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: pain; residual limbs; adjustable socket
• Other Study ID Numbers: 49RC19_0129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No