Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

Amputation Clinical Trial

Official title:

Revofit™ System and Residual Limb Pain in Amputee Patients : Multiple N-of-1 Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04276714
• Other study ID #: 49RC19_0129
• Status: Terminated
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: March 10, 2021

Study information

• Verified date: July 2022
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Disease
• Amputation

Intervention

Other:
• Socket without Revofit system
All the tests are evaluate during one week with the classical type of fittings
• 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)

Locations

Country	Name	City	State
France	DIMONAIS	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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