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Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

NCT04276714 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-07-06

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Mickaël Dinomais · MD University hospital Angers

  • Yoann RONZI · MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2021-03-10
Completion
2021-03-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276714 on ClinicalTrials.gov