Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

NCT04276714 | Terminated

• 1 other identifier: 49RC19_0129
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Adult Disease

Keywords

residual limbs; pain; adjustable socket

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Everyday comfort

  four weeks

• Functional effects in twin task

  Once a week during four weeks

• Functional effects in simple task

  Once a week during four weeks

• Patient satisfaction with assistive technology

  Once a week during four weeks

Study Arms (2)

Adjustable socket

EXPERIMENTAL

First week of the study is with adjustable socket

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

Classical socket

EXPERIMENTAL

First week of the study is with classical socket

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

Interventions

Socket without Revofit system OTHER

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

Adjustable socket; Classical socket

Socket with Revofit system OTHER

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

Adjustable socket; Classical socket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

DIMONAIS

Angers, 49100, France

Location

MeSH Terms

Conditions

Disease; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mickaël Dinomais

  MD University hospital Angers

  PRINCIPAL INVESTIGATOR

• Yoann RONZI

  MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single Case Experimental Design : multiple N of 1 trial

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 19, 2020
• Study Start: February 22, 2021
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)